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

NCT00473928 | Completed Phase 1 DMC

• 1 other identifier: POT-CP1006
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Age-Related Macular Degeneration

Keywords

Macular; degeration; Complement

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Interventions

POT-4 DRUG

Single intravitreal injection.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Potentia Pharmaceuticals, Inc.: lead

Study Sites (6)

United States, Arizona

Tucson, Arizona, 85704, United States

Location

United States, California

Beverly Hills, California, 90211, United States

Location

United States, Florida

Gainesville, Florida, 32610, United States

Location

United States, Florida

Miami, Florida, 33136, United States

Location

United States, Minnesota

Rochester, Minnesota, 55905, United States

Location

United States, New Hampshire

Portsmouth, New Hampshire, 03801, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Jason Slakter, MD

  Potentia Pharmaceuticals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 14, 2007
• First Posted: May 16, 2007
• Study Start: May 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: March 18, 2010

Record last verified: 2010-03

Locations

US (6)