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CompletedNCT02663141Updated Jul 6, 2016

Randomized Clinical Trial of Intravitreal Bevacizumab Versus Intravitreal Bevacizumab Combined With Losartan in the Treatment of Diabetic Macular Edema

A Phase 2 interventional study of Losartan and Intravitreal bevacizumab in Diabetic Macular Edema, sponsored by Tehran University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Per ClinicalTrials.gov, last updated 2016-07-06.

Sponsored by Tehran University of Medical Sciences · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
57
Allocation
Randomized
Sex
All
01

Study summary

The aim of this study is to determine whether oral losartan is effective in the treatment of diabetic macular edema (DME) as an adjuvant for intravitreal bevacizumab (IVB).

02

Conditions studied

  • Diabetic Macular Edema

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03

In context

Macular Edema

841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.

This study's enrollment of 57 is above the median of 50 across 619 interventional studies indexed under Macular Edema.

Browse Macular Edema studies →

Lead sponsor

Tehran University of Medical Sciences is the lead sponsor of 227 studies on the registry; 12 are open to participants now.

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

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

All type 2 diabetes mellitus patients with clinically significant macular edema(CSME), except those mentioned as exclusion criteria

Exclusion criteria

Exclusion Criteria:

  1. Patients with Uncontrolled hypertension
  2. Patients with Proliferative diabetic retinopathy
  3. Patients Who received angiotensin converting enzyme inhibitor(ACEI) or angiotensin receptor blocker(ARB)
  4. Previous treatment for diabetic retinopathy (e.g., laser photocoagulation, photodynamic therapy, intravitreal injections of steroids, or anti-vascular endothelial growth factor, retinal surgery)
  5. media opacities
  6. evidence of any other ocular disease(e.g., glaucoma, uveitis, age related macular degeneration or etc.,)
  7. Pathologic myopia > 6 Diopter
  8. Patients with poor fixation or cooperation
  9. Patients with renal or cardiac disease
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
57 participants (actual)

Study arms

  • Experimental
    Losartan

    Oral losartan 50 mg daily for 6 months

    Drug: Losartan · Drug: Intravitreal bevacizumab

  • Placebo comparator
    Placebo

    Oral placebo daily for 6 months

    Drug: Intravitreal bevacizumab · Drug: Placebo

Interventions

  • DrugLosartan
  • DrugIntravitreal bevacizumab

    Also known as: Avastin

  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. difference in ETDRS best-corrected visual acuity (BCVA) between arms

    Time frame: Within 6 months from therapy

  2. Difference in frequency of intravitreal Bevacizumab injection between arms

    Time frame: Within 6 months from therapy

Secondary outcomes

  1. change in central macular thickness(measured by spectral domain optical coherence tomography)

    Time frame: Within 6 months from therapy

07

Study locations

1 site
  • Farabi Eye Hospital
    Tehran, Iran, Islamic Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02663141
Lead sponsor
Tehran University of Medical Sciences
Collaborators
Farabi Eye Hospital
Responsible party
Sponsor
First posted
Jan 26, 2016
Start date
Jun 2015
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Jul 6, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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