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

This study has been completed.
Sponsor:
Information provided by:
Potentia Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00473928
First received: May 14, 2007
Last updated: March 16, 2010
Last verified: March 2010
  Purpose

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


Condition Intervention Phase
Age-Related Macular Degeneration
Drug: POT-4
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Assessment of Safety of Intravitreal POT-4 Therapy for Patients With Neovascular Age-Related Macular Degeneration (AMD)

Resource links provided by NLM:


Further study details as provided by Potentia Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Local and systemic assessments of participant safety. - Incidence and severity of ocular adverse events - Incidence and severity of non-ocular adverse events [ Time Frame: Within 30 days after POT-4 administration ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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). [ Time Frame: For up to a year after POT-4 administration ] [ Designated as safety issue: Yes ]

Enrollment: 27
Study Start Date: May 2007
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: POT-4
    Single intravitreal injection.
Detailed 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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00473928

Locations
United States, Arizona
United States, Arizona
Tucson, Arizona, United States, 85704
United States, California
United States, California
Beverly Hills, California, United States, 90211
United States, Florida
United States, Florida
Gainesville, Florida, United States, 32610
United States, Florida
Miami, Florida, United States, 33136
United States, Minnesota
United States, Minnesota
Rochester, Minnesota, United States, 55905
United States, New Hampshire
United States, New Hampshire
Portsmouth, New Hampshire, United States, 03801
Sponsors and Collaborators
Potentia Pharmaceuticals, Inc.
Investigators
Principal Investigator: Jason Slakter, MD Potentia Pharmaceuticals
  More Information

No publications provided

Responsible Party: Clinical Research Director, Potentia Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00473928     History of Changes
Other Study ID Numbers: POT-CP1006
Study First Received: May 14, 2007
Last Updated: March 16, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Potentia Pharmaceuticals, Inc.:
Macular
degeration
Complement

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Eye Diseases
Retinal Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on October 21, 2014