Treatment Naive Wet Macular Degeneration

Cedar Study

About The Study:

Principal Investigator: Yevgeniy Shildkrot, MD

Sponsored by Allergan, the purpose of this study is to evaluate the safety and effectiveness of an investigational drug, abicipar, versus ranibizumab in the treatment of wet age-related macular degeneration.

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

Group A—2 mg abicipar administered by intravitreal injection at Day 1, Week 4, and Week 8 followed by doses at 8-week intervals through Week 96
Group B—2 mg abicipar administered by intravitreal injection at Day 1, Week 4, and Week 12 followed by doses at 12-week intervals through Week 96
Group C—0.5 mg ranibizumab administered by intravitreal injection every 4 weeks through Week 96

Participants participating in this study will make up to 27 scheduled study visits over a period of 100 weeks. Each visit will last anywhere from 2-5 hours.

Key Inclusion Criteria:

Age ≥ 50 years
Treatment naïve CNV secondary to AMD
Area of CNV lesion must be > 50% of the total lesion area
BCVA of 20/40-20/320 in the study eye
BCVA of 20/200 or better at baseline in the non-study eye

Key Exclusion Criteria:

History or current evidence or hypersensitivity, allergy, or anaphylactic reaction to iodine
Treatment with systemic anti-VEGF medication or VEGF-receptor inhibitor within 3 months
Use of systemic corticosteroids within 5 days prior to Day 1
History of diabetic retinopathy, DME or any retinal vascular disease other than AMD
Active iris neovascularization, or current evidence of vitreous hemorrhage, or retinal detachment prior to baseline
History of uncontrolled glaucoma (IOP ≥ 25mmHg)
Total lesion size > 12 DA

For additional information about the trials 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