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Clinical Trials/NCT03609307
NCT03609307
Unknown
Phase 2

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 Sciences1 site in 1 country40 target enrollmentSeptember 2018

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.

Registry
clinicaltrials.gov
Start Date
September 2018
End Date
February 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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)

Study Sites (1)

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