Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02634333 · ClinicalTrials.gov registry record · Phase 3
Anti-VEGF Treatment for Prevention of PDR/DME
A Phase 3 study of Diabetic Macular Edema and Diabetic Retinopathy, sponsored by Jaeb Center for Health Research.
- Completed
- Registry status
- Phase 3
- Development phase
- 399
- Enrollment target
- 20
- Study locations
NCT02634333 is a Phase 3 study of Diabetic Macular Edema and Diabetic Retinopathy that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 399 participants, below the 3,788-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 4 states.
The verdict
NCT02634333, a Phase 3 study of Diabetic Macular Edema and Diabetic Retinopathy, has completed, sponsored by Jaeb Center for Health Research.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 399 participants
- Enrollment target
- 20
- Study locations
Study Summary
Multiple studies have implicated vascular endothelial growth factor VEGF as a major causative factor in human eye diseases characterized by neovascularization including proliferative diabetic retinopathy (PDR) and vascular permeability including diabetic macular edema (DME). While there is strong evidence that PDR outcomes are markedly reduced in eyes that are treated with monthly anti-VEGF therapy (A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema (ME) With Center Involvement Secondary to Diabetes Mellitus: RIDE/RISE) and moderately reduced in eyes that received fairly frequent dosing during the 1st year of treatment (Diabetic Retinopathy Clinical Research Network protocol I), it is unknown whether or not an earlier but less frequent dosing regimen would result in similar, favorable anatomic outcomes, and whether favorable anatomic outcomes subsequently would result in favorable visual acuity outcomes. If this study demonstrates that intravitreous aflibercept treatment is effective and safe for reducing the onset of PDR or center involved- DME (CI-DME) in eyes that are at high risk for these complications, a new strategy to prevent vision threatening complications of diabetes will be available for patients. The application of intravitreous aflibercept earlier in the course of disease (i.e., at the time when an eye has baseline severe non-proliferative diabetic retinopathy) could help to reduce future potential treatment burden in patients, at the same time resulting in similar or better long-term visual outcomes, if PDR and DME are prevented. The primary objectives of this protocol are to 1) determine the efficacy and safety of intravitreous aflibercept injections versus sham injections (observation) for prevention of PDR or CI-DME in eyes at high risk for development of these complications and 2) compare long-term visual outcomes in eyes that receive anti-VEGF therapy early in the course of disease with those that are observe
Conditions Studied
Interventions
- PROCEDURE Prompt Sham
- DRUG Prompt aflibercept
- PROCEDURE Deferred laser
- DRUG Deferred aflibercept
Study Locations (20)
California
- Atlantis Eye Care - Huntington Beach
- Loma Linda University Health Care, Department of Ophthalmology - Loma Linda
- East Bay Retina Consultants, Inc. - Oakland
- Southern California Desert Retina Consultants, MC - Palm Desert
- Shashi D Ganti, MD PC - Porterville
- Retina Consultants of Southern California - Redlands
- U.C. Davis Eye Center - Sacramento
- California Retina Consultants - Santa Barbara
- Retinal Consultants of Southern California Medical Group, Inc. - Westlake Village
Florida
- Retina Group of Florida - Fort Lauderdale
- National Ophthalmic Research Institute - Fort Myers
- University of Florida College of Med., Department of Ophthalmology, Jacksonville Health Science Cent - Jacksonville
- Florida Retina Institute-Jacksonville - Jacksonville
- Florida Retina Consultants - Lakeland
- Bascom Palmer Eye Institute - Miami
- Magruder Eye Institute - Orlando
- Florida Retina Institute - Orlando
Arizona
- Arizona Retina and Vitreous Consultants - Phoenix
- University of Arizona Medical Center/Department of Ophthalmology - Tucson
Connecticut
- New England Retina Associates - Hamden
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 399 participants |
| Start Date | 2016-01 |
| Est. Completion | 2022-05-11 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02634333
The ClinicalTrials.gov registry entry for NCT02634333 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 399 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,788-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (89% lower). The listed sponsor is Jaeb Center for Health Research, which has 119 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Diabetic Macular Edema appearing as the primary indexed condition, and to 4 interventions - of which Prompt Sham is the first listed.
NCT02634333 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT02634333 about?
NCT02634333 is a clinical study titled "Anti-VEGF Treatment for Prevention of PDR/DME". Multiple studies have implicated vascular endothelial growth factor VEGF as a major causative factor in human eye diseases characterized by neovascularization including proliferative diabetic retinopathy (PDR) and vascular permeability including diabetic macular edema (DME). While there is strong ev...
What is the current status of trial NCT02634333?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 399 participants. The study started on 2016-01. Estimated completion is 2022-05-11.
What conditions does trial NCT02634333 study?
This clinical trial studies the following conditions: Diabetic Macular Edema, Diabetic Retinopathy.
What interventions are being tested in trial NCT02634333?
The interventions under investigation include: Prompt Sham (PROCEDURE), Prompt aflibercept (DRUG), Deferred laser (PROCEDURE), Deferred aflibercept (DRUG).
Who is sponsoring clinical trial NCT02634333?
This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02634333 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetic Macular Edema
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
RECRUITING · Phase 3
-
A Study to Evaluate Efficacy, Safety & Pharmacokinetics of the Port Delivery System (PDS) With Ranibizumab in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab; A Substudy to Evaluate the Safety of Re-implanting the PDS With Ranibizumab in Participants With DME
RECRUITING · Phase 3
-
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
RECRUITING · Phase 3
-
A Phase 3b, Single-Arm Study of Aflibercept 8 mg Dosed Every 4 Weeks in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME)
ACTIVE NOT RECRUITING · Phase 3
-
A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders
ACTIVE NOT RECRUITING · Phase 3
-
A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 2)
ACTIVE NOT RECRUITING · Phase 3
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.