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

Age-Related Macular Degeneration Clinical Trial

— ASaP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00473928
• Other study ID #: POT-CP1006
• Status: Completed
• Phase: Phase 1
• First received: May 14, 2007
• Last updated: March 16, 2010
• Start date: May 2007
• Est. completion date: February 2010

Study information

• Verified date: March 2010
• Source: Potentia Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

Age-related macular degeneration (AMD) is the leading cause of blindness for individuals over fifty-five years of age that live in the industrialized world. It affects 5-10 million people in the US and as many as 30 million worldwide. There are two forms of the disease, both of which cause a loss of central vision. Approximately eighty-five percent of patients have the less severe dry form that produces gradual but rarely complete vision loss. The remaining fifteen percent have the severe wet, or exudative, form that causes rapid, disabling blindness. Wet AMD is further characterized by choroidal neovascularization (CNV), a growth under the macula of abnormal blood vessels originating from the choroidal capillary bed. Research has linked chronic inflammation to both forms of AMD.

Only recently, unrestrained complement activation was identified in genetic studies to be one of the key mechanisms in the pathogenesis of AMD. It has also been demonstrated that complement activation plays a crucial role in the development of CNV. Therefore, the use of intravitreal complement inhibitors may be beneficial in participants subjects with neovascular AMD.

This prospective, uncontrolled, non-randomized, dose-escalating, pilot Phase I study will provide initial safety and tolerability information on intravitreal complement inhibitor (POT-4) therapy in AMD patients with subfoveal CNV.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• POT-4
Single intravitreal injection.

Locations

Country	Name	City	State
United States	United States, California	Beverly Hills	California
United States	United States, Florida	Gainesville	Florida
United States	United States, Florida	Miami	Florida
United States	United States, New Hampshire	Portsmouth	New Hampshire
United States	United States, Minnesota	Rochester	Minnesota
United States	United States, Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Potentia Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local and systemic assessments of participant safety. - Incidence and severity of ocular adverse events - Incidence and severity of non-ocular adverse events		Within 30 days after POT-4 administration	Yes
Secondary	Secondary outcomes will investigate the safety and further define the efficacy profile including changes in visual acuity, retinal thickening, and CNV lesion (size and composition).		For up to a year after POT-4 administration	Yes