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
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2018
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2018
CompletedFirst Posted
Study publicly available on registry
August 1, 2018
CompletedStudy Start
First participant enrolled
September 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2019
CompletedAugust 1, 2018
July 1, 2018
1 month
July 25, 2018
July 25, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Macular Thickness
Spectral Domain Optical Coherence Tomography
1 month
Secondary Outcomes (1)
Visual acuity
1 month
Study Arms (2)
injection Combined Intravitreal bevacizumab and propranolol
ACTIVE COMPARATORpatients receive two injections at each session Bavacizumab
injection Intravitreal bevacizumab
ACTIVE COMPARATORpatients receive only Bevacizumab
Interventions
these patients receive two injections at each session Bavacizumab and propranolol
these patients receive only Bevacizumab
Eligibility Criteria
You may qualify if:
- Patients with Wet AMD and Vision less than 20/40
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ophthalmic Research Center
Tehran, Iran
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
July 25, 2018
First Posted
August 1, 2018
Study Start
September 1, 2018
Primary Completion
October 1, 2018
Study Completion
February 1, 2019
Last Updated
August 1, 2018
Record last verified: 2018-07