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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

Primary Purpose

Age Related Macular Degeneration

Status

Unknown status

Phase

Phase 2

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Combined Intravitreal bevacizumab and propranolol

Intravitreal bevacizumab

About this trial

This is an interventional treatment trial for Age Related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Ophthalmic Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

injection Combined Intravitreal bevacizumab and propranolol

injection Intravitreal bevacizumab

Arm Description

patients receive two injections at each session Bavacizumab

patients receive only Bevacizumab

Outcomes

Primary Outcome Measures

Macular Thickness

Spectral Domain Optical Coherence Tomography

Secondary Outcome Measures

Visual acuity

Early Treatment Diabetic Retinopathy Study

Full Information

NCT ID

NCT03609307

First Posted

July 25, 2018

Last Updated

July 25, 2018

Sponsor

Shahid Beheshti University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT03609307

Brief 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

Official Title

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Unknown status

Study Start Date

September 2018 (Anticipated)

Primary Completion Date

October 2018 (Anticipated)

Study Completion Date

February 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shahid Beheshti University of Medical Sciences

4. Oversight

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.

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Age Related Macular Degeneration

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

injection Combined Intravitreal bevacizumab and propranolol

Arm Type

Active Comparator

Arm Description

patients receive two injections at each session Bavacizumab

Arm Title

injection Intravitreal bevacizumab

Arm Type

Active Comparator

Arm Description

patients receive only Bevacizumab

Intervention Type

Drug

Intervention Name(s)

Combined Intravitreal bevacizumab and propranolol

Intervention Description

these patients receive two injections at each session Bavacizumab and propranolol

Intervention Type

Drug

Intervention Name(s)

Intravitreal bevacizumab

Intervention Description

these patients receive only Bevacizumab

Primary Outcome Measure Information:

Title

Macular Thickness

Description

Spectral Domain Optical Coherence Tomography

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Visual acuity

Description

Early Treatment Diabetic Retinopathy Study

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ramin Noorinia, MD

Phone

009822591616

labbafi@hotmail.com

Facility Information:

Facility Name

Ophthalmic Research Center

City

Tehran

Country

Iran, Islamic Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ramin Noorinia, MD

Phone

009822591616

labbafi@hotmail.com

12. IPD Sharing Statement

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