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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prompt Panretinal Photocoagulation | Active Comparator | PRP= Panretinal Photocoagulation. PRP alone. |
|
| Bevacizumab with deferred PRP | Experimental | Bevacizumab = Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of visual acuity improvement using Snellen chart or equivalent from baseline and 1 year | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of treatment cost | 1 year | |
| Percent of eyes with vitreous hemorrhage | 1 year | |
| Proportion of eyes with complete regression of neovascularization on fundus photograph |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ameen Marashi, MD | Marashi Eye Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marashi Eye Clinic | Aleppo | 2241511 | Syria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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 |
| Label | URL |
|---|---|
| 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 | View source |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| Panretinal photocoagulation | Procedure | Panretinal photocoagulation (full session completed within 42 days). |
|
| 1 year |
| Proportion of eyes with progression to central subfield involved diabetic macular edema | 1 year |
| Proportion of eyes Need for Vitrectomy | 1 year |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |