Geographic Atrophy

Spectri Study

About The Study:

Principal Investigator: Yevgeniy Shildkrot, MD

Sponsored by F. Hoffman-La Roche, the purpose of this multi-center study is to compare the effects of intravitreal injections of lampalizumab versus sham injections, in participants who have geographic atrophy. This study will also see if people with specific genetic characteristics may have an increased risk of AMD.

All participants will be randomized to one of four study groups. There is a 2 in 3 chance of being assigned to one of the study drug groups and a 1 in 3 chance of being assigned to the sham injection groups. The groups are:

Group A—10 mg of lampalizumab administered via intravitreal injection every 4 weeks
Group B—Sham injection every 4 weeks
Group C—10 mg of lampalizuamb administered via intravitreal injection every 6 weeks
Group D—Sham injection every 6 weeks

Participants participating in this study will make up to 26 scheduled study visits over a period of 24 months. Each visit will last anywhere from 2-5 hours.

Key Inclusion Criteria:

Age ≥ 50 years
BCVA of 20/100 or better in the study eye
Presence of geographic atrophy in both eyes
Lesion in the study eye measuring ≥ 1 DA and ≤ 7 DA

Key Exclusion Criteria:

History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
History of prior CNV in either eye
Previous laser photocoagulation in the study eye
Proliferative diabetic retinopathy in either eye
History of previous intravitreal drug delivery
Uncontrolled glaucoma in the study eye—IOP ≥ 30 mmHg
History of glaucoma filtration surgery

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