Comparison of Treatment Response to Intravitreal Injection of Combined Propranolol and Bevacizumab Versus Bevacizumab Monotherapy in Patients With Wet Age Related Macular Degeneration :A Clinical Trial

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Treatment Response to Intravitreal Injection of Combined Propranolol and Bevacizumab Versus Bevacizumab Monotherapy in Patients With Wet Age Related Macular Degeneration :A Clinical Trial

Conditions
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Age Related Macular Degeneration

Intervention / Treatment
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* Drug: Combined Intravitreal bevacizumab and propranolol
* Drug: Intravitreal bevacizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: injection Combined Intravitreal bevacizumab and propranolol<br>patients receive two injections at each session Bavacizumab | Drug: Combined Intravitreal bevacizumab and propranolol<br>* these patients receive two injections at each session Bavacizumab and propranolol<br>|
| Active Comparator: injection Intravitreal bevacizumab<br>patients receive only Bevacizumab | Drug: Intravitreal bevacizumab<br>* these patients receive only Bevacizumab<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macular Thickness | Spectral Domain Optical Coherence Tomography | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity | Early Treatment Diabetic Retinopathy Study | 1 month |