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

Completed · Phase 1

Conditions studied: Macular Degeneration

In brief

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

Key facts

Study ID

NCT00722384

Run by

OPKO Health, Inc.

People needed

15

Starts

2004-08-01

Expected to finish

2007-12-01

Last updated by the study team

2008-07-25

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• OPKO site — Morristown, New Jersey, United States

Full record on ClinicalTrials.gov

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