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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02663141
Enrollment
57
Registered
2016-01-26
Start date
2015-06-30
Completion date
2016-06-30
Last updated
2016-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema

Brief 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).

Interventions

DRUGLosartan
DRUGPlacebo

Sponsors

Farabi Eye Hospital
CollaboratorOTHER
Tehran University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
difference in ETDRS best-corrected visual acuity (BCVA) between armsWithin 6 months from therapy
Difference in frequency of intravitreal Bevacizumab injection between armsWithin 6 months from therapy

Secondary

MeasureTime frame
change in central macular thickness(measured by spectral domain optical coherence tomography)Within 6 months from therapy

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026