PRP vs Bevacizumab for PDR Treatment

NCT02705274 | Completed Phase 2

• 1 other identifier: Protocol PDR 1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Proliferative Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

• Proportion of visual acuity improvement using Snellen chart or equivalent from baseline and 1 year

  1 year

Secondary Outcomes (5)

• Amount of treatment cost

  1 year

• Percent of eyes with vitreous hemorrhage

  1 year

• Proportion of eyes with complete regression of neovascularization on fundus photograph

  1 year

• Proportion of eyes with progression to central subfield involved diabetic macular edema

  1 year

• Proportion of eyes Need for Vitrectomy

  1 year

Study Arms (2)

Prompt Panretinal Photocoagulation

ACTIVE COMPARATOR

PRP= Panretinal Photocoagulation. PRP alone.

Procedure: Panretinal photocoagulation

Bevacizumab with deferred PRP

EXPERIMENTAL

Bevacizumab = Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.

Drug: Bevacizumab; Procedure: Panretinal photocoagulation

Interventions

Bevacizumab DRUG

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.

Bevacizumab with deferred PRP

Panretinal photocoagulation PROCEDURE

Panretinal photocoagulation (full session completed within 42 days).

Bevacizumab with deferred PRP; Prompt Panretinal Photocoagulation

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Marashi Eye Clinic: lead

Study Sites (1)

Marashi Eye Clinic

Aleppo, 2241511, Syria

Location

Related Publications (1)

• Marashi A, Abukhalaf I, Alfaraji R, Choman Y, Salahieh A (2017) Panretinal Photocoagulation versus Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy Treatment. Adv Ophthalmol Vis Syst 7(1): 00211. DOI: 10.15406/aovs.2017.07.00211

  RESULT

Related Links

• Marashi A, Abukhalaf I, Alfaraji R, Choman Y, Salahieh A (2017) Panretinal Photocoagulation versus Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy Treatment. Adv Ophthalmol Vis Syst 7(1): 00211. DOI: 10.15406/aovs.2017.07.00211

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Ameen Marashi, MD

  Marashi Eye Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Ophthalmologist Retina specialist

Study Record Dates

• First Submitted: February 29, 2016
• First Posted: March 10, 2016
• Study Start: February 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: May 1, 2017
• Last Updated: July 6, 2017

Record last verified: 2017-07

Locations

SY (1)