Infliximab, Sirolimus and Daclizumab to Treat Age-Related Macular Degeneration

PHASE2CompletedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

February 28, 2006

Primary Completion Date

January 31, 2010

Study Completion Date

January 31, 2010

Conditions
Age-Related Macular DegenerationChoroidal Neovascularization
Interventions
DRUG

Intravenous Daclizumab

Participants randomly assigned to intravenous (IV) daclizumab received 8 mg/kg of IV daclizumab at baseline, then 4 mg/kg of IV daclizumab at Week 2 and then 2 mg/kg of IV daclizumab monthly for the rest of the 6-month study.

DRUG

Intravenous Infliximab

Participants randomized to IV infliximab received 3 mg/kg of IV infliximab monthly for 6 months.

OTHER

Observation

Participants randomly assigned to the observation group were given injections of either bevacizumab (1.25 mg/0.05 mL or 2.5 mg/0.1 mL) or ranibizumab (0.5 mg) if they presented with recurrence of intraretinal or subretinal fluid as seen on Stratus Optical Coherence Tomography.

DRUG

Oral Rapamycin

Participants randomly assigned to rapamycin received 2 mg in capsule form every other day for 6 months.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda

All Listed Sponsors
lead

National Eye Institute (NEI)

NIH

NCT00304954 - Infliximab, Sirolimus and Daclizumab to Treat Age-Related Macular Degeneration | Biotech Hunter | Biotech Hunter