NCT02663141

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 26, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 6, 2016

Status Verified

July 1, 2016

Enrollment Period

1 year

First QC Date

January 21, 2016

Last Update Submit

July 3, 2016

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (2)

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

    Within 6 months from therapy

  • Difference in frequency of intravitreal Bevacizumab injection between arms

    Within 6 months from therapy

Secondary Outcomes (1)

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

    Within 6 months from therapy

Study Arms (2)

Losartan

EXPERIMENTAL

Oral losartan 50 mg daily for 6 months

Drug: LosartanDrug: Intravitreal bevacizumab

Placebo

PLACEBO COMPARATOR

Oral placebo daily for 6 months

Drug: Intravitreal bevacizumabDrug: Placebo

Interventions

LosartanDRUG
Losartan
Intravitreal bevacizumabDRUG
Also known as: Avastin
LosartanPlacebo
PlaceboDRUG
Placebo

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Farabi Eye Hospital

Tehran, Tehran Province, Iran

Location

MeSH Terms

Interventions

LosartanBevacizumab

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazolesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2016

First Posted

January 26, 2016

Study Start

June 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

July 6, 2016

Record last verified: 2016-07

Locations

IR(1)