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 (Other)

Overall Status

Unknown status

CT.gov ID

NCT03609307

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Age Related Macular Degeneration	Drug: Combined Intravitreal bevacizumab and propranolol Drug: Intravitreal bevacizumab	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Sep 1, 2018

Anticipated Primary Completion Date :

Oct 1, 2018

Anticipated Study Completion Date :

Feb 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: injection Combined Intravitreal bevacizumab and propranolol patients receive two injections at each session Bavacizumab	Drug: Combined Intravitreal bevacizumab and propranolol these patients receive two injections at each session Bavacizumab and propranolol
Active Comparator: injection Intravitreal bevacizumab patients receive only Bevacizumab	Drug: Intravitreal bevacizumab these patients receive only Bevacizumab

Arm

Intervention/Treatment

Active Comparator: injection Combined Intravitreal bevacizumab and propranolol

patients receive two injections at each session Bavacizumab

Drug: Combined Intravitreal bevacizumab and propranolol

these patients receive two injections at each session Bavacizumab and propranolol

Active Comparator: injection Intravitreal bevacizumab

patients receive only Bevacizumab

Drug: Intravitreal bevacizumab

these patients receive only Bevacizumab

Outcome Measures

Primary Outcome Measures

Macular Thickness [1 month]
Spectral Domain Optical Coherence Tomography

Secondary Outcome Measures

Visual acuity [1 month]
Early Treatment Diabetic Retinopathy Study

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ophthalmic Research Center	Tehran		Iran, Islamic Republic of

Sponsors and Collaborators

Shahid Beheshti University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zahra Rabbani Khah, Clinical Professor, Shahid Beheshti University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT03609307

Other Study ID Numbers:

96301

First Posted:

Aug 1, 2018

Last Update Posted:

Aug 1, 2018

Last Verified:

Jul 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Macular Degeneration

Bevacizumab

Propranolol

Study Results

No Results Posted as of Aug 1, 2018