Overview

This trial is active, not recruiting.

Condition proliferative diabetic retinopathy
Treatments bevacizumab, panretinal photocoagulation
Phase phase 2/phase 3
Target VEGF
Sponsor Marashi Eye Clinic
Start date February 2016
End date August 2017
Trial size 30 participants
Trial identifier NCT02705274, Protocol PDR 1

Summary

Protocol S by DRCR.net has shown that receive Ranibizumab as 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, however with some visual functional benefits and less complications with Ranibizumab arm.

Applying Protocol S in real world scenario may add cost burden to the patient as patients need about 7 injections per year which will cost the patient about 7000 US dollars a year as minimum The primary objective of this protocol is to determine the visual acuity outcomes at 1 year in eyes with proliferative diabetic retinopathy (PDR) using Bevacizumab 1.25 mg instead of Ranbizumab to lower the cost burden

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
PRP= Panretinal Photocoagulation. PRP alone.
panretinal photocoagulation
Panretinal photocoagulation (full session completed within 42 days).
(Experimental)
Bevacizumab = Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.
bevacizumab
Drug: 1.25-mg Bevacizumab Intravitreal injection of 1.25 mg Bevacizumab 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.
panretinal photocoagulation
Panretinal photocoagulation (full session completed within 42 days).

Primary Outcomes

Measure
Proportion of visual acuity improvement using Snellen chart or equivalent from baseline and 1 year
time frame: 1 year

Secondary Outcomes

Measure
Amount of treatment cost
time frame: 1 year
Percent of eyes with vitreous hemorrhage
time frame: 1 year
Proportion of eyes with complete regression of neovascularization on fundus photograph
time frame: 1 year
Proportion of eyes with progression to central subfield involved diabetic macular edema
time frame: 1 year
Proportion of eyes Need for Vitrectomy
time frame: 1 year

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

Inclusion Criteria: - Age >= 18 years - Diagnosis of diabetes mellitus (type 1 or type 2) - Presence of PDR which the investigator intends to manage with PRP alone but for which PRP can be deferred for at least 4 weeks in the setting of intravitreal Bevacizumab , in the investigator's judgment. - Best corrected Snellen equivalent 20/320 or higher on the day of randomization. - Media clarity, pupillary dilation, and study participant cooperation sufficient to administer PRP and obtain adequate fundus photographs and OCT. Exclusion Criteria: - Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant. - Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization - Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization. - For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years. - Tractional retinal detachment involving the macula. -- A tractional retinal detachment is not an exclusion if it is outside of the posterior pole (not threatening the macula) and in the investigator's judgment, is not a contraindication to intravitreal Bevacizumab treatment and also does not preclude deferring PRP for at least 4 weeks in the setting of intravitreal Bevacizumab - Macular edema is present that is considered to be related to ocular surgery such as cataract extraction orclinical exam and/or OCT suggest that vitreoretinal interface abnormalities disease (e.g., a taut posterior hyaloid or epiretinal membrane) is the primary cause of any macular edema. - An ocular condition is present (other than diabetic retinopathy) that, in the opinion of the investigator, might alter visual acuity during the course of the study (e.g., retinal vein or artery occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, - Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye were otherwise normal). - History of intravitreal anti-VEGF treatment at any time in the past 2 months. - History of corticosteroid treatment (intravitreal ) at any time in the past 4 months. - History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization. - Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis - Uncontrolled glaucoma (in investigator's judgment). - Aphakia

Additional Information

Official title Panretinal Photocoagulation Versus Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy
Principal investigator Ameen Marashi, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Marashi Eye Clinic.