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PDT Triple Therapy for Age-Related Macular Degeneration

Phase 4
Waitlist Available
Led By Mark Nelson, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial found that OCTA-directed PDT triple therapy is more effective than standard of care anti-VEGF monotherapy for treating patients with exudative age-related macular degeneration.

Who is the study for?
This trial is for adults with a type of vision loss called Exudative Age-related Macular Degeneration (ARMD) who haven't been treated before. They should be able to follow the study plan and have certain levels of visual acuity. Women who can have children must use birth control. People with recent heart attacks, other eye diseases, or allergies to study drugs can't join.Check my eligibility
What is being tested?
The trial tests a 'triple therapy' using Optical Coherence Tomography Angiography (OCTA) guidance versus standard treatment for ARMD. It includes Ranibizumab injections, Triamcinolone Acetonide, verteporfin, and Photodynamic laser treatment (PDT).See study design
What are the potential side effects?
Possible side effects include eye irritation or discomfort, increased risk of eye infection, changes in intraocular pressure, blurred vision temporarily after treatment sessions and potential allergic reactions to the medications used.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Best corrected visual acuity (BCVA)
Duration of treatment effect
Foveal thickness
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm C: Lucentis, PDT Laser and TriescenseExperimental Treatment4 Interventions
A one time treatment of 0.05ml/0.5mg Lucentis in combination with PDT laser administered at half-fluence and an intravitreal injection of 0.5ml-2mg Triescence at the time of PDT treatment.
Group II: Arm B: Lucentis & PDT LaserExperimental Treatment3 Interventions
A one time treatment of 0.05ml/0.5mg Lucentis in combination with PDT laser administered at half-fluence.
Group III: Arm A: LucentisActive Control1 Intervention
A standard of care treatment of 0.05ml/0.5mg Lucentis given every 4 weeks for 48 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ranibizumab
2017
Completed Phase 4
~2080
Triamcinolone Acetonide
2018
Completed Phase 4
~3730
verteporfin
2012
Completed Phase 2
~290

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,239 Previous Clinical Trials
1,004,183 Total Patients Enrolled
ModulightUNKNOWN
Mark Nelson, MDPrincipal InvestigatorWake Forest University Health Sciences
5 Previous Clinical Trials
133 Total Patients Enrolled

Media Library

Photodynamic laser treatment (PDT) Clinical Trial Eligibility Overview. Trial Name: NCT04075136 — Phase 4
Age-Related Macular Degeneration Research Study Groups: Arm C: Lucentis, PDT Laser and Triescense, Arm A: Lucentis, Arm B: Lucentis & PDT Laser
Age-Related Macular Degeneration Clinical Trial 2023: Photodynamic laser treatment (PDT) Highlights & Side Effects. Trial Name: NCT04075136 — Phase 4
Photodynamic laser treatment (PDT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04075136 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical concerns can Ranibizumab be utilized to treat?

"Ranibizumab is a therapeutic agent used to address ulcerative colitis, hand conditions and brain pathologies."

Answered by AI

Are enrollees still being accepted for this scientific experiment?

"Unfortunately, this research trial is not currently open to recruitment. It was initially made available on November 1st 2022 and the latest revision occurred on August 23rd 2022. In terms of other opportunities, there are 159 studies that are actively searching for individuals with macular degeneration and 74 trials recruiting patients who have been prescribed Ranibizumab."

Answered by AI

What detrimental effects have been associated with Ranibizumab?

"According to our team at Power, Ranibizumab is considered safe and has been granted a score of 3. This medication is currently in Phase 4 clinical trials which suggest it may be approved soon."

Answered by AI

Is this research study enrolling participants who are more than half a century of age?

"This medical experiment allows individuals who are aged between 50 and 90 to participate."

Answered by AI

What is the aggregate sum of participants in this clinical experiment?

"This study is no longer recruiting participants, having been last updated on August 23rd 2022. However, if you are interested in macular degeneration trials there are presently 159 studies actively seeking volunteers and 74 for Ranibizumab."

Answered by AI

Is it feasible for me to partake in this research project?

"This clinical trial is admitting 150 patients with age between 50 and 90 who are suffering from macular degeneration. To qualify, individuals must meet the requirements of having exudative ARMD with evidence of choroidal neovascularization (type 1, 2 or 3) on spectral domain OCT, fluorescein angiography, indocyanine green angiogram and optical coherent tomography angiography; visual acuity ranging from 20/25 to 20/400 at screening and baseline visits using an autorefractor or Early Treatment Diabetic Retinopathy Study; intraocular pressure not exceeding 25mmHG;"

Answered by AI

Could you provide information on prior investigations of Ranibizumab?

"Presently, 74 medical trials are evaluating the efficacy of ranibizumab. Of them, 22 are in phase 3 and they span 897 different sites across Columbia Missouri."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
What portion of applicants met pre-screening criteria?
Did not meet criteria
~0 spots leftby Nov 2024