Open Label Study for the Evaluation of Tolerability of Five Dose Levels of Cand5

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To establish the tolerability and preliminary efficacy of Cand5 by a single intravitreal injection in patients with wet age-related macular degeneration.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OPKO Health, Inc.

Criteria

Inclusion Criteria:

• Patients with subfoveal predominantly classic, minimally classic and purely occult lesions, secondary to age related macular degeneration, with a total lesion size (including blood, atrophy/scar and neovascularization) of < 12 total disc areas, of which at least 50% are active CNV.

• Patients must have visual acuity 20/50 to 20/320 in the study eye.

• Patients must have better visual acuity in the fellow eye than the study eye.

• Subretinal hemorrhage (if any) must comprise no more than 50% of total lesion size.

Exclusion Criteria:

• Patients with concomitant eye disease, including glaucoma, uveitis, diabetic retinopathy, presence of pigment epithelial tears or rips, acute ocular or periocular infection in the study eye.

• Patients with > 3 prior PDT treatments with Visudyne in the study eye.

• Patients who received PDT in the study eye within eight weeks prior to the baseline angiography/photography.