NCT01489189

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

Prompt Panretinal Photocoagulation Versus Intravitreal Ranibizumab With Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 305 (actual)
• Sponsor: Jaeb Center for Health Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2012-03-01
• Primary completion: 2015-01-01
• Completion: 2018-02-05
• First posted: 2011-12-09
• Last updated: 2021-10-29
• Results posted: 2016-06-01

Locations

48 sites across 1 country: United States