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201 Clinical Trials near Cape Coral, FL
Power is an online platform that helps thousands of patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerAZD9833 + CDK4/6 Inhibitor for Breast Cancer
Fort Myers, Florida
The study is intended to show superiority of AZD9833 in combination with CDK4/6 inhibitor (palbociclib, abemaciclib or ribociclib) versus aromatase inhibitors (anastrozole or letrozole) in combination with CDK4/6 inhibitor in patients with hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative) metastatic breast cancer with detectable ESR1 mutation.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:CNS Metastases, Severe Heart Disease, Others
Must Be Taking:CDK4/6 Inhibitors, AIs
315 Participants Needed
Durvalumab + Tremelimumab + Enfortumab Vedotin for Bladder Cancer
Fort Myers, Florida
This trial tests a new combination of cancer treatments for bladder cancer patients who can't use standard chemotherapy. It uses drugs that help the immune system fight cancer and a drug that targets and kills cancer cells directly.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Metastatic Disease, Active Infection, Others
Must Not Be Taking:Immunosuppressants
712 Participants Needed
Selpercatinib for Non-Small Cell Lung Cancer
Fort Myers, Florida
This trial is testing if the drug selpercatinib can safely and effectively prevent lung cancer from returning in patients who have had treatment. It focuses on people with early-stage lung cancer. The drug works by blocking proteins that help cancer cells grow.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Other Oncogenic Drivers, Small Cell Lung Cancer, Interstitial Lung Disease, Cardiovascular Disease, Others
Must Not Be Taking:Selective RET Inhibitors
152 Participants Needed
MRTX849 + Cetuximab for Colorectal Cancer
Cape Coral, Florida
This trial is testing a new treatment for patients with colorectal cancer. The treatment combines two drugs that work together to block cancer growth and prevent its spread. One of the drugs has shown promise in treating other types of cancer as well.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Active Brain Metastasis, Others
Must Not Be Taking:KRAS Inhibitors, Anti-EGFR
461 Participants Needed
AZD9833 + Palbociclib for Breast Cancer
Fort Myers, Florida
This trial is comparing two drug combinations to treat a specific type of advanced breast cancer. One combination includes a new drug called camizestrant, and the other includes anastrozole. Both combinations also use palbociclib. The goal is to see which combination works better at slowing down the cancer.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:CNS Metastases, Heart Disease, Others
Must Be Taking:LHRH Agonists
1370 Participants Needed
LOXO-305 for Mantle Cell Lymphoma
Fort Myers, Florida
This is a study for participants with a type of blood cancer called mantle cell lymphoma (MCL). The main purpose is to compare pirtobrutinib (LOXO-305) to other drugs that work in a similar way that have already been approved by the United States Food and Drug Administration (US FDA). Participation could last up to two years, and possibly longer, if the disease does not progress.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Bleeding Diathesis, Stroke, Cardiovascular, HIV, Others
Must Not Be Taking:BTK Inhibitors, CYP3A4 Inducers
500 Participants Needed
Triple Drug Therapy for Advanced Melanoma
Fort Myers, Florida
This trial is testing a combination of three drugs to treat advanced skin cancer in patients with a specific genetic mutation. One drug helps the immune system fight cancer, while the other two stop cancer cells from growing. The study aims to see if this combination is safe and effective.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Immunodeficiency, Autoimmune, Cardiovascular, Others
Must Not Be Taking:CYP3A4 Inhibitors
257 Participants Needed
NCX 470 for Glaucoma
Fort Myers, Florida
This trial is testing NCX 470 eye drops to see if they can safely and effectively lower eye pressure in people with high eye pressure or glaucoma. The goal is to protect their vision by reducing the pressure inside their eyes. NCX 470 is a nitric oxide (NO)-donating bimatoprost with clinically demonstrated pressure-lowering effects.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Narrow Angles, Ocular Disease, Surgery, Others
696 Participants Needed
T-DXd vs. T-DM1 for Residual Breast Cancer
Fort Myers, Florida
Patients with HER2-positive primary breast cancer (BC) who do not achieve complete response after appropriate neoadjuvant therapy are at higher risk of disease recurrence. More effective treatment options are needed for this patient population. This study will examine the efficacy and safety of trastuzumab deruxtecan (T-DXd) compared with trastuzumab emtansine (T-DM1) in high-risk patients with residual invasive breast cancer following neoadjuvant therapy.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Stage IV BC, Prior Breast Cancer, Others
Must Be Taking:Taxane Chemotherapy, HER2-directed Treatment
1600 Participants Needed
Adagrasib + Pembrolizumab for Lung Cancer
Fort Myers, Florida
This trial tests two drugs, MRTX849 and pembrolizumab, in patients with advanced lung cancer who have a specific genetic mutation. MRTX849 targets the mutation to stop cancer growth, while pembrolizumab boosts the immune system to fight the cancer. The study aims to see how well these treatments work alone and together.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Active Brain Metastases, Seizures, Others
Must Not Be Taking:Chemotherapy, Immune Checkpoint Inhibitors
806 Participants Needed
Durvalumab + FLOT for Gastric Cancer
Fort Myers, Florida
This trial is testing whether adding durvalumab to a standard chemotherapy mix around the time of surgery can help patients with stomach or gastroesophageal cancer. Durvalumab helps the immune system fight cancer, while the chemotherapy drugs kill cancer cells.
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Metastasis, Adenosquamous Carcinoma, Transplant, Others
Must Not Be Taking:Immunosuppressants
957 Participants Needed
Acalabrutinib + R-CHOP for Diffuse Large B-Cell Lymphoma
Fort Myers, Florida
This trial tests if adding acalabrutinib to the standard R-CHOP chemotherapy is more effective for patients aged 75 or younger with untreated non-germinal center diffuse large B-cell lymphoma. Acalabrutinib blocks a protein that helps cancer cells grow, while R-CHOP uses multiple drugs to kill cancer cells.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:CNS Lymphoma, Cardiovascular Disease, Others
611 Participants Needed
Capivasertib + Abiraterone for Prostate Cancer
Fort Myers, Florida
This study will assess the efficacy and safety of capivasertib plus abiraterone (+prednisone/prednisolone) plus androgen deprivation therapy (ADT) versus placebo plus abiraterone (+prednisone/prednisolone) plus ADT in participants with mHSPC whose tumours are characterised by PTEN deficiency. The intention of the study is to demonstrate that in participants with mHSPC, the combination of capivasertib plus abiraterone (+prednisone/prednisolone) plus ADT is superior to placebo plus abiraterone (+prednisone/prednisolone) plus ADT in participants with mHSPC characterised by PTEN deficiency with respect to radiographic progression-free survival (rPFS) per 1) Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for soft tissue and/or Prostate Cancer Working Group (PCWG3) for bone as assessed by the investigator 2) death due to any cause.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Sex:Male
Key Eligibility Criteria
Disqualifiers:Diabetes, Heart Disease, Lung Disease, Others
Must Be Taking:Androgen Deprivation Therapy
1012 Participants Needed
AVP-786 for Alzheimer's-related Agitation
Cape Coral, Florida
This trial tests a combination of two drugs taken by mouth to help calm severe agitation in people with Alzheimer's disease by balancing brain chemicals.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:50 - 90
Key Eligibility Criteria
Disqualifiers:Non-Alzheimer's Dementia, Unstable Systemic Diseases, Myasthenia Gravis, Others
241 Participants Needed
Tazemetostat + Lenalidomide + Rituximab for Follicular Lymphoma
Fort Myers, Florida
The participants of this study would have relapsed/refractory follicular lymphoma.
Follicular lymphoma is a type of blood cancer. It is referred to as 'relapsed' when the disease has come back after a period of improvement after that follows a treatment regimen and 'refractory' when treatment no longer works.
Stage 1 of this trial will study the safety and the level that adverse effects of each of the study drug combinations can be tolerated (known as tolerability). It is also designed to establish a recommended study drug dosage for stage 2 and 3. Stage 1 of the study is completed.
Stages 2 and 3 will evaluate and compare how long participants live without their disease getting worse when receiving the study drug in combination with other drug treatment versus the placebo (dummy drug) in combination with other drug treatment.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Prior Tazemetostat, Lenalidomide, Brain Metastases, Others
Must Be Taking:Lenalidomide
612 Participants Needed
SAR408701 vs Docetaxel for Non-Small Cell Lung Cancer
Fort Myers, Florida
Primary Objectives:
* Study was designed with multiple primary endpoints analyzed on randomized participants at the time of the cut-off date for each given analysis (progression free survival \[PFS\] and overall survival \[OS\])
* Study success was defined either on PFS or OS
* The primary objective was to determine whether tusamitamab ravtansine improves the progression free survival (PFS) when compared to docetaxel in participants with metastatic non-squamous non-small-cell lung cancer (NSCLC) expressing CEACAM5 greater than or equal to 2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor (ICI)
* The primary objective was to determine whether tusamitamab ravtansine improves the overall survival (OS) when compared with docetaxel in participants with metastatic non-squamous NSCLC expressing CEACAM5 greater than or equal to 2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor.
Secondary Objectives:
* Compared the objective response rate (ORR) of tusamitamab ravtansine with docetaxel
* Compared the health-related quality of life (HRQOL) of tusamitamab ravtansine with docetaxel
* Evaluated the safety of tusamitamab ravtansine compared to docetaxel
* Assessed the duration of response (DOR) of tusamitamab ravtansine as compared with docetaxel
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Untreated Brain Metastases, AIDS, Others
Must Not Be Taking:Anticancer Therapy, Antiretrovirals
389 Participants Needed
Nemolizumab for Eczema
Cape Coral, Florida
Long-Term Safety and Efficacy of Nemolizumab in Subjects with Moderate-to-Severe Atopic Dermatitis Description
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:12+
Key Eligibility Criteria
Disqualifiers:Pregnancy, Low Body Weight, Others
Must Not Be Taking:Antibiotics, Antivirals, Antifungals
1700 Participants Needed
Tucatinib + T-DM1 for Breast Cancer
Cape Coral, Florida
This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery.
Patients in this study will be randomly assigned to get either tucatinib or placebo (a pill with no medicine). This is a blinded study, so neither patients nor their doctors will know whether a patient gets tucatinib or placebo. All patients in the study will get T-DM1, a drug that is often used to treat this cancer.
Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills two times every day. Patients will get T-DM1 injections from the study site staff on the first day of every cycle.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Untreated Brain Lesions, Leptomeningeal Disease, Others
Must Be Taking:T-DM1
466 Participants Needed
Sitravatinib + Nivolumab for Advanced Non-Small Cell Lung Cancer
Fort Myers, Florida
This study will compare the efficacy of the investigational agent sitravatinib in combination with nivolumab versus docetaxel in patients with advanced non-squamous NSCLC who have previously experienced disease progression on or after platinum-based chemotherapy and checkpoint inhibitor therapy.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Brain Metastases, EGFR Mutations, Others
577 Participants Needed
Immunotherapy for Small Cell Lung Cancer
Fort Myers, Florida
This trial is testing whether Durvalumab alone or with Tremelimumab can help patients with a specific type of lung cancer who have already had initial treatment. The drugs aim to boost the immune system to fight off any remaining cancer cells. Durvalumab and Tremelimumab are being studied together for their potential to improve cancer treatment outcomes.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Extensive-stage SCLC, Autoimmune Disorders, Infections, Others
Must Be Taking:Platinum, Etoposide
730 Participants Needed
Why Other Patients Applied
"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."
ID
Pancreatic Cancer PatientAge: 40
"I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."
ZS
Depression PatientAge: 51
"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."
FF
ADHD PatientAge: 31
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."
AG
Paralysis PatientAge: 50
Abrocitinib for Atopic Dermatitis/Eczema
Cape Coral, Florida
This trial is testing a pill called Abrocitinib to help people aged 12 and older with severe eczema. It aims to see if the pill can reduce inflammation and itching by blocking certain body chemicals. The study includes patients who have already participated in a related study.
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:12+
Key Eligibility Criteria
Disqualifiers:Other Skin Diseases, Psychiatric Conditions, Others
3166 Participants Needed
EYE103 for Diabetic Macular Edema
Fort Myers, Florida
EYE-RES-103 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of EYE103 in comparison with the active control, ranibizumab, in patients with diabetic macular edema (DME).
In the first year, all 3 treatment groups will be treated every 4 weeks with either EYE103 or ranibizumab. Beginning at Year 2, the frequency of treatment for participants will shift based on a personalized treatment interval algorithm.
Approximately 960 participants will be entered in the study.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, Recent Eye Surgery, Others
Must Not Be Taking:Retinal Toxicity Drugs
960 Participants Needed
AP301 for High Phosphate Levels
Fort Myers, Florida
The goal of this clinical trial is to learn if AP301 could work in the patients receiving maintenance dialysis with elevated blood phosphate. The main questions it aims to answer are:
* Does AP301 lower blood phosphate levels?
* Does AP301 works on serum calcium level, calcium times phosphate level, and intact parathyroid hormone level?
* What discomfort or medical problem do the patients have when taking AP301?
* Does AP301 improve quality of life in Chinese patients?
The researchers will compare AP301 to an ineffective comparator (a look-alike substance that contains low dose AP301) to see if AP301 works to treat elevated blood phosphate.
In the study, the patients will experience the following stages in a chronicle order:
* Stop all using blood phosphate-lowering drugs,
* Take AP301 or the comparator three times a day for 8 weeks,
* Take AP301 three times a day for 24 weeks, and
* Take AP301 or the comparator three times a day for 3 weeks.
In the first 32 weeks, the dose of AP301 will be adjusted upwards or downwards based on the patient's blood phosphate level and the study doctor's judgment.
If the participant has a blood phosphate level above or below a certain level, they may receive additional treatment to lower the blood phosphate level.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:12+
Key Eligibility Criteria
Disqualifiers:Kidney Transplant, Parathyroid Intervention, GI Disorder, Others
Must Be Taking:Phosphate Binders
264 Participants Needed
Daraxonrasib for Non-Small Cell Lung Cancer
Fort Myers, Florida
The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:CNS Metastases, Cardiovascular, Lung, Others
Must Not Be Taking:Direct RAS-targeted, Docetaxel
420 Participants Needed
Buntanetap for Alzheimer's Disease
Fort Myers, Florida
The goal of this clinical trial is to learn if buntanetap/Posiphen works to treat early Alzheimer's disease in adults aged 55-85. It will also learn about the safety of buntanetap/Posiphen. The main questions it aims to answer are:
* Does buntanetap/Posiphen improve cognition as measured by ADAS-Cog13?
* Does buntanetap/Posiphen improve function as measured by ADCS-iADL?
* What medical issues do participants have, if any, when taking buntanetap/Posiphen?
Researchers will compare buntanetap/Posiphen to a placebo (a look-alike substance that contains no drug) to see if buntanetap/Posiphen works to treat early Alzheimer's disease.
Participants will:
* Take buntanetap/Posiphen or a placebo every day for 18 months
* Visit the clinic periodically for checkups, tests, and questionnaires (screening visits, enrollment, month 1, month 3, month 6, month 9, month 12, month 15, month 18), including a volumetric MRI at month 6 and month 18
* Complete pre- and post-clinic visit phone calls
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:55 - 85
Key Eligibility Criteria
Disqualifiers:Schizophrenia, Bipolar, Major Depression, Others
Must Be Taking:Cholinesterase Inhibitors, Memantine
760 Participants Needed
EYP-1901 vs Aflibercept for Age-Related Macular Degeneration
Fort Myers, Florida
This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:50+
Key Eligibility Criteria
Disqualifiers:Subfoveal Fibrosis, Atrophy, Scarring, Others
Must Be Taking:Anti-VEGF Injections
400 Participants Needed
Surgery + Chemotherapy for Pleuropulmonary Blastoma
Fort Myers, Florida
This phase III trial tests how well surgery plus chemotherapy compared to surgery alone works in treating patients with type I pleuropulmonary blastoma (PPB), and tests how well surgery plus standard chemotherapy with the addition of topotecan works compared to surgery plus standard chemotherapy alone in treating patients with type II and III PPB.
Historically, most children with type I PPB had surgery and approximately 40% of children with type I PPB received chemotherapy following their surgery, usually for 22-42 weeks. There has not been a consistent standard for which children with type I PPB receive chemotherapy after surgery. For patients whose tumor has been removed completely with surgery, observation without chemotherapy may work as well as giving chemotherapy after surgery in preventing a return of the PPB tumor.
The standard chemotherapy for patients with types II or III PPB in the United States is four cycles of IVADo (ifosfamide, vincristine, dactinomycin, and doxorubicin) followed by 8 cycles of IVA (ifosfamide, vincristine and dactinomycin). Ifosfamide is in a class of medications called alkylating agents. It works by slowing or stopping the growth of tumor cells in the body. Vincristine is in a class of medications called vinca alkaloids. It works by stopping tumor cells from growing and dividing and may kill them. Dactinomycin is a type of antibiotic that is only used in cancer chemotherapy (antineoplastic antibiotic). It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill tumor cells. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill tumor cells. It also blocks a certain enzyme needed for cell division and DNA repair. Topotecan is in a class of medications called topoisomerase I inhibitors. It works by interfering with tumor cell DNA which kills them. Giving topotecan in addition to standard IVADo and IVA chemotherapy regimens may shrink the cancer as well as or better than the standard therapy or could decrease the chance the tumor spreads while causing fewer side effects.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:< 21
Key Eligibility Criteria
Disqualifiers:Prior Chemotherapy, Charcot-Marie-Tooth, Pregnancy, Others
Must Not Be Taking:Antiretrovirals
110 Participants Needed
Survodutide for Fatty Liver Disease
Fort Myers, Florida
This study is open to adults who are at least 18 years old and have:
* A confirmed liver disease called non-alcoholic steatohepatitis (NASH) or
* A confirmed liver disease called metabolic-associated steatohepatitis (MASH)
* BMI of 27 kg/m2 or more or
* 25 kg/m2 or more if the participant is Asian.
People with a history of other chronic liver diseases or high alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with NASH or MASH improve their liver function.
Participants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. All participants regularly receive counselling to make changes to their diet and to exercise regularly.
Participants are in the study for up to 4 and a half years. During this time, they visit the study site or have a remote visit by video call every 2, 4 or 6 weeks for about a 1 year and 5 months. After this time participants visit the trial site or have a remote visit every 3 months until the end of the study.
The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. At some visits the liver parameters are measured using different imaging methods. The participants also fill in questionnaires about their symptoms. The results are compared between the groups to see whether the treatment works.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Chronic Liver Diseases, Hepatitis B, Hepatitis C, Others
1590 Participants Needed
Survodutide for Fatty Liver Disease
Fort Myers, Florida
This study is open to adults who are at least 18 years old living with obesity and have:
* a confirmed liver disease called non-alcoholic steatohepatitis (NASH)/metabolic associated steatohepatitis (MASH) and
* moderate or advanced liver fibrosis
People with a history of acute or chronic liver diseases other than MASH or chronic alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with MASH and moderate or advanced liver fibrosis improve their liver function.
This study has 2 parts. The purpose of the first part of this study is to find out the effect of survodutide on MASH and liver fibrosis. The purpose of the second part is to find out how safe and effective survodutide is in improving liver function. Participants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. The survodutide doses are slowly increased until the target dose is reached. All participants receive counselling to make changes to their diet and to exercise regularly.
Participants are in the study for up to 7 years. During this time, they regularly visit the study site or have remote visits by video call. For about the first year of the study, participants have these visits every 2 weeks, increasing to every 4 weeks and then every 6 weeks. After being in the study for a little over a year participants will then alternate between visiting the study site or having a remote visit every 3 months until the end of the study.
The doctors check participants' health and take note of any unwanted effects. The participants' body weight and effects on the stomach and intestines are regularly measured. At some visits the liver is measured using different imaging methods. At 2 or 3 visits doctors take a small sample of liver tissue (biopsy). The participants also fill in questionnaires about their symptoms and quality of life. The results are compared between the groups to see whether the treatment works.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Other Liver Diseases, Liver Cirrhosis, Hepatocellular Carcinoma, Others
Must Not Be Taking:Obesity Medications
1800 Participants Needed
EYE103 for Diabetic Macular Edema
Fort Myers, Florida
EYE-RES-102 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of EYE103 in comparison with the active control, ranibizumab, in patients with diabetic macular edema (DME)
In the first year, all 3 treatment groups will be treated every 4 weeks with either EYE103 or ranibizumab. Beginning at Year 2, the frequency of treatment for participants will shift based on a personalized treatment interval algorithm.
Approximately 960 participants will be entered in the study.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, Cataract Surgery, Others
Must Not Be Taking:Retinal Toxicity Drugs
984 Participants Needed
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Bask GillCEO at Power
Frequently Asked Questions
How much do clinical trials in Cape Coral, FL pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do clinical trials in Cape Coral, FL work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across trials in Cape Coral, FL 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length in Cape Coral, FL is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility in Cape Coral, FL several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a medical study in Cape Coral, FL?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest clinical trials in Cape Coral, FL?
Most recently, we added Pumitamig + Chemotherapy for Colorectal Cancer, Mirena for Endometrial Hyperplasia and Intraperitoneal Paclitaxel for Stomach Cancer to the Power online platform.
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