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Combined Intravitreal Fasudil and Bevacizumab for Diabetic Macular Edema

NCT01823081 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2017-05-11

No results posted yet for this study

Summary

Eligible eyes are randomized to two groups. Group A will receive three intravitreal injections of bevacizumab at 4 week intervals. In group B, three intravitreal injections of combined bevacizumab and fasudil will be performed with the same frequency.

Best corrected visual acuity (BCVA) and central macular thickness (CMT) will be evaluated prior to injections and then every 4 weeks for 6 months. Fluorescein angiography will be performed at baseline and at weeks 12 and 24. The two groups will be compared in terms of BCVA and CMT changes.

Conditions

Interventions

DRUG

Intravitreal injection of bevacizumab (Avastin)

DRUG

Intravitreal injection of fasudil and bevacizumab (Avastin)

intravitreal injections of bevacizumab and fasudil are performed at two different sites (superior temporal and inferior temporal quadrants respectively)

Sponsors & Collaborators

  • Shahid Beheshti University of Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-06-30
Completion
2015-12-31

Countries

  • Iran

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01823081 on ClinicalTrials.gov