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
Overview
- Phase
- Phase 2
- Intervention
- Combined Intravitreal bevacizumab and propranolol
- Conditions
- Age Related Macular Degeneration
- Sponsor
- Shahid Beheshti University of Medical Sciences
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Macular Thickness
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Investigators
Zahra Rabbani Khah
Clinical Professor
Shahid Beheshti University of Medical Sciences
Eligibility Criteria
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
Arms & Interventions
injection Combined Intravitreal bevacizumab and propranolol
patients receive two injections at each session Bavacizumab
Intervention: Combined Intravitreal bevacizumab and propranolol
injection Intravitreal bevacizumab
patients receive only Bevacizumab
Intervention: Intravitreal bevacizumab
Outcomes
Primary Outcomes
Macular Thickness
Time Frame: 1 month
Spectral Domain Optical Coherence Tomography
Secondary Outcomes
- Visual acuity(1 month)