INV-102 for Diabetic Macular Edema
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is studying an eye drop treatment called INV-102 for diabetic macular edema (DME), a diabetes-related condition that causes vision problems. The researchers aim to determine if these drops can reduce swelling and improve vision in individuals with two types of DME: non-center involved (NCIDME) and center-involved (CIDME). Participants must have diabetes and moderate to severe non-proliferative diabetic retinopathy (NPDR) in the eye being studied, and they should not have received laser treatment on that eye in the past year. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in DME treatment.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatment is likely to be safe?
Research has shown that INV-102 has been tested in people before and has successfully completed at least one previous human trial, indicating a positive safety profile. In earlier studies, INV-102 was used as eyedrops, helping researchers understand how well people can tolerate the treatment.
The current trial focuses on assessing both the safety and effectiveness of INV-102, suggesting it has already demonstrated some safety in past tests. However, new side effects could still emerge.
For those considering joining a trial for INV-102, it is reassuring that the treatment has been tested in people before. Nonetheless, discussing any concerns with a doctor is always advisable.12345Why do researchers think this study treatment might be promising for diabetic macular edema?
INV-102 is unique because it offers a new approach to treating Diabetic Macular Edema (DME) with its 0.7% ophthalmic solution. Unlike standard treatments like anti-VEGF injections, INV-102 is administered as eye drops, potentially providing a less invasive option with more convenient dosing. Researchers are excited about its potential to target inflammation in the eye, which could lead to improved outcomes for patients with both non-center-involved (NCIDME) and center-involved DME (CIDME). This novel delivery method could enhance patient comfort and compliance while addressing the condition effectively.
What evidence suggests that INV-102 might be an effective treatment for diabetic macular edema?
Research has shown that INV-102 eyedrops are under investigation for their potential to help with diabetic macular edema (DME). This condition involves swelling in the retina caused by diabetes, which can affect vision. Early findings suggest the eyedrops might help reduce this swelling. INV-102 targets specific pathways in the eye that lead to the swelling. Although data remains limited, initial results appear promising for treating both non-center and center-involved DME, where swelling occurs in different parts of the retina. This trial will evaluate INV-102 in two separate parts: one for non-center involved DME and another for center-involved DME. Further studies will help confirm these benefits.46789
Who Is on the Research Team?
Robert Shalwitz
Principal Investigator
Invirsa, Inc.
Are You a Good Fit for This Trial?
This trial is for adults with a specific eye condition called non-center involved diabetic macular edema (NCIDME), which is related to diabetes and affects the retina. Participants should have this condition without severe progression that requires immediate surgery.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive INV-102 Ophthalmic Solution for 12 weeks in NCIDME and 8 weeks in CIDME
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- INV-102
Trial Overview
The study tests INV-102 eyedrops' effectiveness over 12 weeks in patients with NCIDME associated with non-proliferative diabetic retinopathy, aiming to reduce retinal swelling and improve vision.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
INV-102 0.7% Ophthalmic Solution given three times daily (TID) for 2 weeks followed by twice daily (BID) for 6 weeks
INV-102 0.7% Ophthalmic Solution given three times daily (TID) for 2 weeks followed by twice daily (BID) for 10 weeks
Find a Clinic Near You
Who Is Running the Clinical Trial?
Invirsa, Inc.
Lead Sponsor
Citations
Study of INV-102 Ophthalmic Solution in Adults With ...
Phase 2 study to assess the efficacy of topically administered eyedrops of INV-102 during a 12-week dosing period in subjects with ...
INV-102 for Diabetic Macular Edema
Trial Overview The study tests INV-102 eyedrops' effectiveness over 12 weeks in patients with NCIDME associated with non-proliferative diabetic retinopathy, ...
One-Year Anti-VEGF Therapy Outcomes in Diabetic ...
This registry analysis found that overall VA and anatomic outcomes tended to be better in DME eyes treated at a greater proportion of visits in the first year ...
Persistent Diabetic Macular Edema - PubMed Central - NIH
Several studies have highlighted the potential for improvement in anatomical and visual outcome when switched to ranibizumab or aflibercept in ...
One-Year Anti-VEGF Therapy Outcomes in Diabetic ...
The mean (95% confidence interval [CI]) VA change after 12 months of treatment was 3.6 (2.8–4.4) letters for eyes in Group A versus 5.2 ...
6.
ctv.veeva.com
ctv.veeva.com/study/study-of-inv-102-ophthalmic-solution-in-adults-with-non-center-involved-diabetic-macular-edema-assocStudy of INV-102 Ophthalmic Solution in Adults With Diabetic ...
Phase 2 study to assess the efficacy of topically administered eyedrops of INV-102 during a 12-week dosing period in subjects with ...
INV-102 - Drug Targets, Indications, Patents
The cornea is highly sensitive to SM toxicity and exposure to low vapor doses can cause incapacitating acute injuries. Exposure to higher doses can elicit ...
8.
trial.medpath.com
trial.medpath.com/clinical-trial/25c93992a8e6d21d/nct06599684-inv-102-ophthalmic-solution-diabetic-macular-edemaStudy of INV-102 Ophthalmic Solution in Adults With Diabetic ...
Phase 2 study to assess the efficacy of topically administered eyedrops of INV-102 during a 12-week dosing period in subjects with non-center involved DME ...
Diabetic macular edema (DME) - PubMed Central - NIH
The first-line treatment for DME is anti-VEGF family drugs, such as ranibizumab, brolucizumab, bevacizumab, and aflibercept.
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