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

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: October 2018

Interventions

  • Drug: Combined Intravitreal bevacizumab and propranolol
    • these patients receive two injections at each session Bavacizumab and propranolol
  • Drug: Intravitreal bevacizumab
    • these patients receive only Bevacizumab

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Macular Thickness
    • Time Frame: 1 month
    • Spectral Domain Optical Coherence Tomography

Secondary Measures

  • Visual acuity
    • Time Frame: 1 month
    • Early Treatment Diabetic Retinopathy Study

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Shahid Beheshti University of Medical Sciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: Zahra Rabbani Khah, Clinical Professor – Shahid Beheshti University of Medical Sciences
  • Overall Contact(s)
    • Ramin Noorinia, MD, 009822591616, labbafi@hotmail.com

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