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In this randomized 3-armed clinical trial, 105 eyes with PDR will be included and divided randomly into 3 groups: IVB group (35 eyes) that receive 4 monthly IVB injections and then rescue IVB, PRP group (35 eyes) that undergo full PRP in 2 or 3 sessions and then rescue IVB, and combination group (35 eyes) that receive 2 bimonthly IVB injections and a modified laser (1 session anterior to the equator) and then rescue IVB or laser. Diabetic macular edema (DME) will be treated independently in all groups by IVB. Primary outcome will be the number and activity of neovascularizations at 4,8 and 12 months and secondary measures will be changes in best corrected visual acuity (BCVA) and central macular thickness (CMT), and number of examinations and injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intravitreal bevacizumab injections and then rescue | Active Comparator |
| |
| PRP group | Active Comparator |
| |
| IVB injections and a modified laser | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| receive 4 monthly IVB injections and then rescue IVB | Drug | IVB group that receive 4 monthly IVB injections and then rescue IVB |
|
| Measure | Description | Time Frame |
|---|---|---|
| Extent of neovascular tissues in disc-diameter measured by investigator according to the wide-field FAG | Number of neovascular tissue counted by investigator according to FAG | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Best corrected visual acuity based on Snellen chart | 12 months | |
| Central retinal thickness according to macular OCT | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alireza Ramezani, MD | Contact | 009822591616 | labbafi@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmic Research Center | Recruiting | Tehran | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35594075 | Derived | Shahraki T, Arabi A, Nourinia R, Beheshtizadeh NF, Entezari M, Nikkhah H, Karimi S, Ramezani A. PANRETINAL PHOTOCOAGULATION VERSUS INTRAVITREAL BEVACIZUMAB VERSUS A PROPOSED MODIFIED COMBINATION THERAPY FOR TREATMENT OF PROLIFERATIVE DIABETIC RETINOPATHY: A Randomized Three-Arm Clinical Trial (CTPDR Study). Retina. 2022 Jun 1;42(6):1065-1076. doi: 10.1097/IAE.0000000000003450. |
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| PRP group | Drug | PRP group that undergo full PRP in 2 or 3 sessions and then rescue IVB |
|
| IVB injections and a modified laser | Drug | Combination group that receive 2 bimonthly IVB injections and a modified laser (1 session anterior to the equator) and then rescue IVB or laser |
|