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PRP vs Bevacizumab for PDR Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02705274
Recruitment Status : Completed
First Posted : March 10, 2016
Last Update Posted : July 6, 2017
Sponsor:
Information provided by (Responsible Party):
Ameen Marashi, Marashi Eye Clinic

Study Description
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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


Condition or disease Intervention/treatment Phase
Proliferative Diabetic Retinopathy Drug: Bevacizumab Procedure: Panretinal photocoagulation Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Panretinal Photocoagulation Versus Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy
Study Start Date : February 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Prompt Panretinal Photocoagulation
PRP= Panretinal Photocoagulation. PRP alone.
 Procedure: Panretinal photocoagulation
Panretinal photocoagulation (full session completed within 42 days).
Experimental: Bevacizumab with deferred PRP
Bevacizumab = Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.
 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).


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of visual acuity improvement using Snellen chart or equivalent from baseline and 1 year [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Amount of treatment cost [ Time Frame: 1 year ]
  2. Percent of eyes with vitreous hemorrhage [ Time Frame: 1 year ]
  3. Proportion of eyes with complete regression of neovascularization on fundus photograph [ Time Frame: 1 year ]
  4. Proportion of eyes with progression to central subfield involved diabetic macular edema [ Time Frame: 1 year ]
  5. Proportion of eyes Need for Vitrectomy [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02705274


Locations
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Syrian Arab Republic
Marashi Eye Clinic
Aleppo, Syrian Arab Republic, 2241511
Sponsors and Collaborators
Marashi Eye Clinic
Investigators
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Principal Investigator: Ameen Marashi, MD Marashi Eye Clinic
More Information
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Additional Information:

Publications of Results:
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

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Responsible Party: Ameen Marashi, MD, Ophthalmologist Retina specialist, Marashi Eye Clinic
ClinicalTrials.gov Identifier: NCT02705274    
Other Study ID Numbers: Protocol PDR 1
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
 Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors