Overview

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

Status:
Completed
Trial end date:
2018-02-28
Target enrollment:
0
Participant gender:
All
Summary
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kagawa University
Collaborator:
Novartis Pharmaceuticals
Treatments:
Ranibizumab
Criteria
Inclusion Criteria:

1. Diabetic macular edema involving the foveal center

2. Male or female of aged 18 years or older

3. Decrease of visual acuity (VA) due to macular edema

4. Signed informed consent form

Exclusion Criteria:

1. Previous treatment with anti-VEGF drugs or corticosteroid or grid laser
photocoagulation

2. Ocular disorders in the study eye that may confound interpretation of study results

3. History of vitrectomy surgery, or other surgical intervention other than the cataract
surgery

4. The pregnant or lactating woman