| Registry | NCT03609307 |
|---|---|
| Status | Unknown |
| Phase | Phase 2 / Phase 3 |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 40 (Estimated) |
| Sponsor | Shahid Beheshti University of Medical Sciences (Other) |
| Conditions | Age Related Macular Degeneration |
| Interventions | Combined Intravitreal bevacizumab and propranolol, Intravitreal bevacizumab (Drug) |
| Dates | start 2018-09-01 (estimated), primary completion 2018-10-01 (estimated), completion 2019-02-01 (estimated), first posted 2018-08-01, last updated 2018-08-01 |
| Locations | 1 site in Iran |
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All trials for Age Related Macular Degeneration All trials of Combined Intravitreal bevacizumab and propranolol All trials of Intravitreal bevacizumab
This study is designed to compare the effect of combined intravitreal Bevacizumab and Propranolol injection versus Bevacizumab monotherapy in patients with Age Related Macular Degeneration.
Methods:
In this study patients with Age Related Macular Degeneration who are naïve or had history of previous treatment are included. The eligible patients in randomized in two groups "Bevacizumab" and "Bavacizumab + propranolol" and in injected intravitreally for 3 times monthly. In "Bevacizumab+propranolol" group patients receive two injections at each session Bavacizumab and propranolol. In "Bevacizumab" group patients receive only Bevacizumab. The patients are followed for 6 months and central macular thickness and visual acuity is measured at baseline and monthly for 6 month. Baseline ancillary exams include Fluorescein Angiography and OCT-Angiography which is performed at the final exam as well. Patients needing any therapeutic intervention is addressed during the 6 month follow up period.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| injection Combined Intravitreal bevacizumab and propranolol | Active comparator | Drug: Combined Intravitreal bevacizumab and propranolol | patients receive two injections at each session Bavacizumab |
| injection Intravitreal bevacizumab | Active comparator | Drug: Intravitreal bevacizumab | patients receive only Bevacizumab |
Sex: All, ages: 50 Years to any, accepts healthy volunteers
Inclusion Criteria: * Patients with Wet AMD and Vision less than 20/40 Exclusion Criteria: * History of cardiac ,renal, respiratory diseases (due to beta blocker toxicity), * Associated with other Macular abnormalities such as Diabetic Retinopathy, Macular traction * History of ocular inflammation * Subretinal fibrosis * History of Cataract surgey less than 6 months * History of Glaucoma Surgery ,Vitreoretinal surgery * Media opacity
| Facility | City | Country | Status |
|---|---|---|---|
| Ophthalmic Research Center | Tehran | Iran | Recruiting |