Treatment Naive Wet Macular Degeneration

Avenue Study

About The Study:

Sponsored by F. Hoffman-La Roche, the purpose of this multi-center study is to compare the effects of an investigational drug, RO6867461, versus ranibizumab, in participants who have treatment naïve wet macular degeneration.

All participants will be randomized to one of five study groups. Participants have a 1 in 6 chance of being assigned to groups B, C, or D and a 1 in 4 chance of being assigned to groups A or E.

Group A—0.5 mg of ranibizumab administered via intravitreal injection into the study eye every 4 weeks for 8 months (9 injections in total)
Group B—1.5 mg of RO6867461 administered via intravitreal injection into the study eye every 4 weeks for 8 months (9 injections in total)
Group C—6 mg of RO6867461 administered via intravitreal injection into the study eye every 4 weeks for 8 months (9 injections in total)
Group D—6 mg of RO6867461 administered via intravitreal injection into he study eye every 4 weeks for 4 injections, followed by every 8 weeks for 2 injections. In between the week 8 injections, participants are given a sham injection
Group E—0.5 mg of ranibizumab administered via intravitreal injection into the study eye every 4 weeks for 2 months (3 injections) followed by 6 mg of RO6867461 into the study eye every 4 weeks until month 8 (6 injections)

Participants participating in this study will make up to 13 scheduled study visits over a period of 36 weeks. Each visit will last anywhere from 2-5 hours. Participants are compensated $50 per completed study visit. Sponsor covers cost of all study procedures and study drug.

Key Inclusion Criteria:

Age ≥ 50 years
Treatment naïve CNV secondary to AMD
BCVA of 20/40-20/320 in the study eye

Key Exclusion Criteria:

CNV due to causes other than AMD
History of vitrectomy, glaucoma surgery, or corneal transplant in the study eye
Prior history of IVT treatment with any anti-VEGF agent

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