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Combination Therapy for PDR
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.
Details
| Lead sponsor | Shahid Beheshti University of Medical Sciences |
|---|---|
| Phase | Phase 2 |
| Status | UNKNOWN |
| Enrolment | 105 |
| Start date | 2020-03-01 |
| Completion | 2021-12 |
Conditions
- Proliferative Diabetic Retinopathy
Interventions
- receive 4 monthly IVB injections and then rescue IVB
- PRP group
- IVB injections and a modified laser
Primary outcomes
- Extent of neovascular tissues in disc-diameter measured by investigator according to the wide-field FAG — 12 months
Number of neovascular tissue counted by investigator according to FAG
Countries
Iran