Safety of Intravitreal POT-4 Therapy for Patients With Neovascular Age-Related Macular Degeneration (AMD)

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to provide initial safety and tolerability information of intravitreal POT-4 for treatment of patients with AMD

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

Details

• Lead Sponsor: Potentia Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

• Understand and sign the IRB-approved informed consent document for the study.

• Age ≥ 50 years.

• In the study eye, diagnosis of exudative AMD defined by the presence of drusen larger than 63 μm.

• In the study eye, the presence of a choroidal neovascular lesion, either predominantly or minimally classic or occult with no classic in nature, determined by the Digital Angiography Reading Center (DARC) with the CNV defined by its fluorescein angiographic (FA) features.

• The lesion must contain some visible active CNV, but the active CNV need not be under the fovea itself.

• Visual acuity of 20/60 or worse in the study eye as measured on an ETDRS chart.

• Retinal photographs and angiography of sufficient quality, allowing assessment of the macular area according to standard clinical practice, can be obtained.

• Willingness to comply with the protocol.

Exclusion Criteria:

• Choroidal neovascularization in the study eye associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis or posterior uveitis, etc.

• Decreased vision, in the study eye, due to retinal disease not attributable to CNV, such as nonexudative forms of AMD, geographic atrophy, inherited retinal dystrophy, uveitis or epiretinal membrane, a vitelliform-like lesion of the outer retina (e.g., as in pattern dystrophies or basal laminar drusen), idiopathic parafoveal telangiectasis, or central serous retinopathy. Participants who have any additional ocular diseases that have irreversibly compromised or, during follow-up, could likely compromise the VA of the study eye including amblyopia, anterior ischemic optic neuropathy, clinically significant diabetic macular edema, severe non proliferative diabetic retinopathy, or proliferative diabetic retinopathy.

• Decreased vision, in the study eye, due to significant media opacity such as corneal disease or cataract, or opacity precluding photography of the retina.

• Cataract surgery within three months of enrolment.

• Presence of hemorrhage greater than 50% of the CNV lesion.

• Previous PDT treatment in the study eye (eye to be treated) within 30 days prior to enrollment in the study.

• Previous extrafoveal or juxtafoveal thermal laser photocoagulation in the study eye (eye to be treated) is allowed, if performed at least 30 days prior to enrollment in the study.

• Previous Macugen (pegaptanib) injection in the study eye (eye to be treated) within 30 days prior to enrollment in the study.

• Previous Lucentis (ranibizumab) injection in the study eye (eye to be treated) within 30 days prior to enrollment in the study.

• Previous Avastin (bevacizumab) injection in the study eye (eye to be treated) within 30 days prior to enrollment in the study.

• Previous corticosteroid injection in the study eye (eye to be treated) within 180 days prior to enrollment in the study.

• History of peribulbar corticosteroid injection within 6 months prior to the start of the trial.

• History of oral steroid use at any time during the 30 days prior to randomization.

• Intraocular surgery (including lens replacement surgery) within 6 weeks prior to randomization.

• Participation in any other clinical study or are receiving, or have received any experimental systemic treatment for AMD (e.g.: retinoic acid, thalidomide) or any other investigational new drug within 12 weeks prior to the start of study treatment.

• Medical problems that make consistent follow-up over the treatment period unlikely (e.g. stroke, severe MI, end stage malignancy), or in general a poor medical risk because of other systemic diseases or active uncontrolled infections.

• Advance coronary artery disease or cerebral vascular disease.

• Premenopausal women not using adequate contraception

• Pregnancy or lactation

• Hypersensitivity to Fluorescein