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Prompt Panretinal Photocoagulation Versus Ranibizumab+Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy

NCT01489189 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 305

Last updated 2021-10-29

Study results available
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Summary

The primary objective of the protocol is to determine if visual acuity outcomes at 2 years in eyes with proliferative diabetic retinopathy (PDR) that receive anti-vascular endothelial growth factor (anti-VEGF) therapy with deferred panretinal photocoagulation (PRP) are non-inferior to those in eyes that receive standard prompt PRP therapy.

Secondary objectives include:

* Comparing other visual function outcomes (including Humphrey visual field testing and study participant self-reports of visual function) in eyes receiving anti-VEGF with deferred PRP with those in eyes receiving prompt PRP.
* Determining percent of eyes not requiring PRP when anti-VEGF is given in the absence of prompt PRP.
* Comparing safety outcomes between treatment groups.
* Comparing associated treatment and follow-up exam costs between treatment groups.

Conditions

  • Proliferative Diabetic Retinopathy

Interventions

OTHER

Prompt Panretinal Photocoagulation

Panretinal photocoagulation alone at baseline (full session completed within 56 days).

DRUG

0.5-mg Ranibizumab

Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.

OTHER

Deferred panretinal photocoagulation

PRP is deferred until failure/futility criteria for intravitreal injection are met.

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • Genentech, Inc.

    collaborator INDUSTRY

  • Jaeb Center for Health Research

    lead OTHER

Principal Investigators

  • Jeffrey G Gross, MD · Carolina Retina Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2015-01-31
Completion
2018-02-05

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01489189 on ClinicalTrials.gov