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

Age Related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03609307
• Other study ID #: 96301
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: September 2018
• Est. completion date: February 2019

Study information

• Verified date: July 2018
• Source: Shahid Beheshti University of Medical Sciences
• Contact: Ramin Noorinia, MD
• Phone: 009822591616
• Email: labbafi[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Ophthalmic Research Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Macular Thickness	Spectral Domain Optical Coherence Tomography	1 month
Secondary	Visual acuity	Early Treatment Diabetic Retinopathy Study	1 month