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
- Age Related Macular Degeneration
- Interventions
- Registration Number
- NCT03609307
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- Patients with Wet AMD and Vision less than 20/40
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description injection Combined Intravitreal bevacizumab and propranolol Combined Intravitreal bevacizumab and propranolol patients receive two injections at each session Bavacizumab injection Intravitreal bevacizumab Intravitreal bevacizumab patients receive only Bevacizumab
- Primary Outcome Measures
Name Time Method Macular Thickness 1 month Spectral Domain Optical Coherence Tomography
- Secondary Outcome Measures
Name Time Method Visual acuity 1 month Early Treatment Diabetic Retinopathy Study
Trial Locations
- Locations (1)
Ophthalmic Research Center
🇮🇷Tehran, Iran, Islamic Republic of