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

Sponsor
Shahid Beheshti University of Medical Sciences
Study ID
NCT03609307
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

  • Age Related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

First listed
Aug 1, 2018
Start date
Sep 30, 2018
Status verified
Jul 2018
Primary completion
Oct 31, 2018
Completion
Feb 28, 2019

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: injection Combined Intravitreal bevacizumab and propranolol
    patients receive two injections at each session Bavacizumab
  • Active Comparator: injection Intravitreal bevacizumab
    patients receive only Bevacizumab

Primary Outcome Measure

Macular Thickness [ Time Frame: 1 month ]

Central Contacts

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