A Study of RO6867461 in Participants With Center-involving Diabetic Macular Edema
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Ocular |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/20/2018 |
| Start Date: | April 27, 2016 |
| End Date: | December 14, 2017 |
A Multiple-center, Multiple-dose, Randomized, Active Comparator−Controlled, Double-masked, Parallel Group, 36-week Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO6867461 Administered Intravitreally in Patients With Diabetic Macular Edema
This is a multiple-center, multiple-dose, randomized, active comparator-controlled,
double-masked, three parallel group, 36-week study in participants with center-involving
diabetic macular edema (DME). Only one eye will be selected as the study eye. Where both eyes
meet all eligibility criteria, the eye with the worse best corrected visual acuity (BCVA)
will be defined as the study eye. The study will consist of a treatment period (20 weeks) and
an observational period (up to 16 weeks). Treatment naive participants will be randomized in
a 1:1:1 ratio to one of the Arms A, B and C, respectively. Participants previously treated
with intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) will be randomized in
a 1:1 ratio to Arms A and C.
double-masked, three parallel group, 36-week study in participants with center-involving
diabetic macular edema (DME). Only one eye will be selected as the study eye. Where both eyes
meet all eligibility criteria, the eye with the worse best corrected visual acuity (BCVA)
will be defined as the study eye. The study will consist of a treatment period (20 weeks) and
an observational period (up to 16 weeks). Treatment naive participants will be randomized in
a 1:1:1 ratio to one of the Arms A, B and C, respectively. Participants previously treated
with intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) will be randomized in
a 1:1 ratio to Arms A and C.
Inclusion Criteria:
- Macular edema associated with diabetic retinopathy
- Decreased visual acuity attributable primarily to DME
- Diagnosis of diabetes mellitus
Exclusion Criteria:
- High risk proliferative diabetic retinopathy
- Cataract surgery within 3 months of Baseline, or any other previous intraocular
surgery
- Uncontrolled glaucoma
- Current or history of ocular disease in the study eye other than DME
- Major illness or major surgical procedure within 1 month prior to Day 1
- Uncontrolled blood pressure
- Glycosylated hemoglobin (HbA1c) greater than (>) 12 percent (%) at screening
- Untreated diabetes mellitus or initiation of oral anti-diabetic medication or insulin
within 4 months prior to Day 1
We found this trial at
76
sites
University of Illinois at Chicago A major research university in the heart of one of...
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University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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525 East 68th Street
New York, New York 10065
New York, New York 10065
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8411 North Run Medical Drive
Richmond, Virginia 23226
Richmond, Virginia 23226
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