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CompletedNCT02705274Updated Jul 6, 2017

PRP vs Bevacizumab for PDR Treatment

A Phase 2/3 interventional study of Bevacizumab and Panretinal photocoagulation in Proliferative Diabetic Retinopathy, sponsored by Marashi Eye Clinic. Completed at 1 site in Syrian Arab Republic. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2017-07-06.

Sponsored by Marashi Eye Clinic · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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

02

Conditions studied

  • Proliferative Diabetic Retinopathy

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03

In context

Diabetic Retinopathy

778 studies on the registry are indexed under Diabetic Retinopathy; 142 are open to participants now.

This study's enrollment of 30 is below the median of 80 across 481 interventional studies indexed under Diabetic Retinopathy.

Browse Diabetic Retinopathy studies →

Lead sponsor

Marashi Eye Clinic is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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, , 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 : 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 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 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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    Prompt Panretinal Photocoagulation

    PRP= Panretinal Photocoagulation. PRP alone.

    Procedure: Panretinal photocoagulation

  • Experimental
    Bevacizumab with deferred PRP

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

    Drug: Bevacizumab · Procedure: Panretinal photocoagulation

Interventions

  • 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.

  • ProcedurePanretinal photocoagulation

    Panretinal photocoagulation (full session completed within 42 days).

06

What researchers measure

Primary outcomes

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

    Time frame: 1 year

Secondary outcomes

  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

07

Study locations

1 site
  • Marashi Eye Clinic
    Aleppo, 2241511, Syrian Arab Republic
08

References and documents

Publications

  • 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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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02705274
Lead sponsor
Marashi Eye Clinic
Responsible party
Ameen Marashi (MD, Ophthalmologist Retina specialist, Marashi Eye Clinic) — Principal investigator
First posted
Mar 10, 2016
Start date
Feb 2016
Primary completion
Apr 2017
Completion
May 2017
Last update
Jul 6, 2017

Study contacts

Ameen Marashi, MD
principal investigator · Marashi Eye Clinic
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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