Change Oxygen Consumption Following Intravitreal Treatment of Lucentis (Ranibizumab) in Eyes With Diabetic Macular Edema

Sponsor
Kagawa University
Study ID
NCT02329132
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab — DRUG
    Each eye will be treated with three initial monthly injections of intravitreal ranibizumab 0.5 mg (Lucentis), followed by retreatment as needed, guided by monthly clinical examinations including biomicroscopy, VA measurement, and optical coherence tomography (OCT) examination.

Study Details

Recent reports suggest that anti-VEGF agents (ranibizumab) may suppress the progression of retinal nonperfusion area. This protective effect would cause the increase of the oxygen consumption in the diabetic retina. We expect that the current study using the retinal oximetry would show the protective effects of ranibizumab on the hypoxia in the diabetic retina. This study is designed to analyze the effects of ranibizumab (Lucentis) to the retinal oxygen saturation or consumption in eyes with diabetic macular edema.

Key Dates

First listed
Dec 31, 2014
Start date
Nov 30, 2015
Status verified
Mar 2018
Primary completion
Jan 28, 2018
Completion
Feb 28, 2018

Study Design

Enrollment
30 participants (actual)

Primary Outcome Measure

The change of retinal oxygen saturation and consumption from baseline at 6 months [ Time Frame: At 6 months after ranibizumab (Lucentis) treatment. ]

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