Diabetic Macular Edema

Boulevard Study

About The Study:

Sponsored by F. Hoffman-La Roche Ltd, the purpose of this study is to compare the effects of an investigational drug, RO6867461, versus ranibizumab in participants with center-involving diabetic macular edema (CI-DME).

All participants will be randomized to one of three study groups:

Group A – 0.3 mg ranibizumab administered by invtravitreal injections every 4 weeks, a total of 7 injections
Group B – 1.5 mg of RO6867461 administered by invtravitreal injections every 4 weeks, a total of 6 injections and 1 sham injection
Group C—6 mg of of RO6867461 administered by invtravitreal injections every 4 weeks, a total of 6 injections and 1 sham injection

Participants participating in this study will make up to 11 scheduled study visits over a period of 36 weeks. Each visit will last anywhere from 2-5 hours.

Key Inclusion Criteria:

Age ≥ 18 years
Treatment naïve DME in study eye
BCVA of 20/40-20/320 in the study eye
CST of ≥325µm

Key Exclusion Criteria:

Any PDR in study eye
Any IVT anti-VEGF treatment in study eye
Any PRP treatment
Macular laser photocoagulation within 3 months
History of vitreoretinal surgery
Any IVT, topical, periocular corticosteroid or corticosteroid implants treatment
History of incisional glaucoma surgery
Uncontrolled glaucoma— IOP ≥ 25mmHg

For additional information on any study or to refer a patient contact the study coordinators:

Ashton Leone, MPH at (434) 243-5737 or aml7q@virginia.edu
Tamika Mercer at (434) 243-2852 or tmm2v@virginia.edu