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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

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ClinicalTrials.gov Identifier: NCT03609307
Recruitment Status : Unknown
Verified July 2018 by Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : August 1, 2018
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Macular Thickness [ Time Frame: 1 month ]
    Spectral Domain Optical Coherence Tomography


Secondary Outcome Measures :
  1. Visual acuity [ Time Frame: 1 month ]
    Early Treatment Diabetic Retinopathy Study


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03609307


Contacts
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Contact: Ramin Noorinia, MD 009822591616 labbafi@hotmail.com

Locations
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Iran, Islamic Republic of
Ophthalmic Research Center Recruiting
Tehran, Iran, Islamic Republic of
Contact: Ramin Noorinia, MD    009822591616    labbafi@hotmail.com   
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
More Information
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Responsible Party: Zahra Rabbani Khah, Clinical Professor, Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03609307    
Other Study ID Numbers: 96301
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Propranolol
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
 Physiological Effects of Drugs
Growth Inhibitors
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents