Status:
COMPLETED
Open Label Study for the Evaluation of Tolerability of Five Dose Levels of Cand5
Lead Sponsor:
OPKO Health, Inc.
Conditions:
Macular Degeneration
Eligibility:
All Genders
55+ years
Phase:
PHASE1
Brief Summary
To establish the tolerability and preliminary efficacy of Cand5 by a single intravitreal injection in patients with wet age-related macular degeneration.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00722384
Start Date
August 1 2004
End Date
December 1 2007
Last Update
July 25 2008
Active Locations (1)
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1
OPKO site
Morristown, New Jersey, United States