PRP vs Bevacizumab for PDR Treatment

Proliferative Diabetic Retinopathy Clinical Trial

Official title:

Panretinal Photocoagulation Versus Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02705274
• Other study ID #: Protocol PDR 1
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 29, 2016
• Last updated: July 3, 2017
• Start date: February 2016
• Est. completion date: May 2017

Study information

• Verified date: July 2017
• Source: Marashi Eye Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Proliferative Diabetic Retinopathy
• Retinal Diseases

Intervention

Drug:
• 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.

Procedure:
• Panretinal photocoagulation
Panretinal photocoagulation (full session completed within 42 days).

Locations

Country	Name	City	State
Syrian Arab Republic	Marashi Eye Clinic	Aleppo

Sponsors (1)

Lead Sponsor	Collaborator
Marashi Eye Clinic

Country where clinical trial is conducted

Syrian Arab Republic, 

References & 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of visual acuity improvement using Snellen chart or equivalent from baseline and 1 year		1 year
Secondary	Amount of treatment cost		1 year
Secondary	Percent of eyes with vitreous hemorrhage		1 year
Secondary	Proportion of eyes with complete regression of neovascularization on fundus photograph		1 year
Secondary	Proportion of eyes with progression to central subfield involved diabetic macular edema		1 year
Secondary	Proportion of eyes Need for Vitrectomy		1 year

External 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