PRP vs Bevacizumab for PDR Treatment

NCT ID: NCT02705274

Last Updated: 2017-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2017-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prompt Panretinal Photocoagulation

PRP= Panretinal Photocoagulation. PRP alone.

Group Type: ACTIVE_COMPARATOR

Panretinal photocoagulation

Intervention Type: PROCEDURE

Panretinal photocoagulation (full session completed within 42 days).

Bevacizumab with deferred PRP

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

Group Type: EXPERIMENTAL

Bevacizumab

Intervention Type: 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.

Panretinal photocoagulation

Intervention Type: PROCEDURE

Panretinal photocoagulation (full session completed within 42 days).

Interventions

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.

Intervention Type: DRUG

Panretinal photocoagulation

Panretinal photocoagulation (full session completed within 42 days).

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marashi Eye Clinic

OTHER

Sponsor Role: lead

Responsible Party

Ameen Marashi

MD, Ophthalmologist Retina specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ameen Marashi, MD

Role: PRINCIPAL_INVESTIGATOR

Marashi Eye Clinic

Locations

Marashi Eye Clinic

Aleppo, , Syria

Countries

Syria

References

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

Reference Type: RESULT

Related Links

http://medcraveonline.com/AOVS/AOVS-07-00211.pdf

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

Other Identifiers

Protocol PDR 1

Identifier Type: -

Identifier Source: org_study_id