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
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
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 →Marashi Eye Clinic is the lead sponsor of 4 studies on the registry; none are open to participants now.
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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.
Exclusion Criteria:
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.
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.
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PRP= Panretinal Photocoagulation. PRP alone.
Procedure: Panretinal photocoagulation
Bevacizumab = Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.
Drug: Bevacizumab · Procedure: Panretinal photocoagulation
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 (full session completed within 42 days).
Proportion of visual acuity improvement using Snellen chart or equivalent from baseline and 1 year
Time frame: 1 year
Amount of treatment cost
Time frame: 1 year
Percent of eyes with vitreous hemorrhage
Time frame: 1 year
Proportion of eyes with complete regression of neovascularization on fundus photograph
Time frame: 1 year
Proportion of eyes with progression to central subfield involved diabetic macular edema
Time frame: 1 year
Proportion of eyes Need for Vitrectomy
Time frame: 1 year
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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Studies of the drug tested here: Bevacizumab
Marashi Eye Clinic