CClinicalTrials.gg
Status unknownNCT03609307Updated Aug 1, 2018

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

A Phase 2/3 interventional study of Combined Intravitreal bevacizumab and propranolol and Intravitreal bevacizumab in Age Related Macular Degeneration, sponsored by Shahid Beheshti University of Medical Sciences. Status unknown at 1 site in Iran, Islamic Republic of. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-01.

Sponsored by Shahid Beheshti University of Medical Sciences · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Age Related Macular Degeneration
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's planned enrollment of 40 is below the median of 51 across 985 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Shahid Beheshti University of Medical Sciences is the lead sponsor of 221 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients with Wet AMD and Vision less than 20/40

Exclusion criteria

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    injection Combined Intravitreal bevacizumab and propranolol

    patients receive two injections at each session Bavacizumab

    Drug: Combined Intravitreal bevacizumab and propranolol

  • Active comparator
    injection Intravitreal bevacizumab

    patients receive only Bevacizumab

    Drug: Intravitreal bevacizumab

Interventions

  • DrugCombined Intravitreal bevacizumab and propranolol

    these patients receive two injections at each session Bavacizumab and propranolol

  • DrugIntravitreal bevacizumab

    these patients receive only Bevacizumab

06

What researchers measure

Primary outcomes

  1. Macular Thickness

    Spectral Domain Optical Coherence Tomography

    Time frame: 1 month

Secondary outcomes

  1. Visual acuity

    Early Treatment Diabetic Retinopathy Study

    Time frame: 1 month

07

Study locations

1 of 1 sites recruiting
  • Ophthalmic Research Center
    Tehran, Iran, Islamic Republic of
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03609307
Lead sponsor
Shahid Beheshti University of Medical Sciences
Responsible party
Zahra Rabbani Khah (Clinical Professor, Shahid Beheshti University of Medical Sciences) — Principal investigator
First posted
Aug 1, 2018
Start date
Sep 2018 (estimated)
Primary completion
Oct 2018 (estimated)
Completion
Feb 2019 (estimated)
Last update
Aug 1, 2018

Study contacts

Ramin Noorinia, MD
Contact
labbafi@hotmail.com
009822591616

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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