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

Shahid Beheshti University of Medical Sciences

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Age Related Macular Degeneration

Treatments: Drug: Combined Intravitreal bevacizumab and propranolol; Drug: Intravitreal bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT03609307

96301

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

injection Combined Intravitreal bevacizumab and propranolol

Active Comparator group

Description:

patients receive two injections at each session Bavacizumab

Treatment:

Drug: Combined Intravitreal bevacizumab and propranolol

injection Intravitreal bevacizumab

Active Comparator group

Description:

patients receive only Bevacizumab

Treatment:

Drug: Intravitreal bevacizumab