Clinical trial NCT02228304: Study of the Intravitreal Implantation of NT-503-3 Encapsulated Cell Technology (ECT) for the Treatment of Recurrent Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)
Official title: A Multi-Center, Two-Stage, Open-Label Phase I and Randomized, Active Controlled, Masked Phase II Study to Evaluate the Safety and Efficacy of Intravitreal Implantation of NT-503-3 Encapsulated Cell Technology Compared With Eylea for the Treatment of Recurrent CNV Secondary to AMD
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Macular Degeneration
Keywords: Wet AMD
Wet Age Related Macular Degeneration
Recurrent CNV Secondary to AMD
Active subfoveal CNV
Lead sponsor: Neurotech Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-08-29
Enrollment: 42
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective, multi-center 2-stage study. Stage 1 (Phase I) is open-label with all patients treated with the NT-503-3 ECT implant. Stage 1 (Phase I) patients will undergo explantation at year 2. Those who, in the opinion of the investigator, are still candidates for continued anti-VEGF therapy will be re-implanted with a new NT-503-3 investigational product and followed for an additional 12 weeks before study exit. Stage 2 (Phase II) is a separate, randomized, masked phase during which eligible patients will be randomized to the NT-503-3 group or the control group.

Clinical Hypotheses:

* NT-503-3 ECT is comparable to Eylea® injected intravitreally every 8 weeks in the prevention of vision loss due to recurrent CNV secondary to AMD
* NT-503-3 ECT has an acceptable safety profile


Eligibility criteria: Key Inclusion Criteria:

* Diagnosis of Active (recurrent or persistent) subfoveal CNV lesions secondary to AMD in the study eye
* Prior Intravitreal Anti-VEGF injections

Key Exclusion Criteria:

* Significant subretinal hemorrhage
* Significant Scar and/or, fibrosis
* Suspected polypoidal choroidopathy, or pigment epithelial tears or rips
* Inadequate response to anti-VEGF therapy

Primary outcomes:
measure: Percentage of patients with less than a 3-line loss of BCVA in ETDRS letters
timeFrame: Week 52 and Week 108
Secondary outcomes:
measure: Change from baseline in best corrected visual acuity (BCVA)
timeFrame: Week 52
measure: Change from baseline in macular thickness as determined by Spectral Domain Optical Coherence Tomography (sdOCT)
timeFrame: Up to Week 108
measure: Mean (median) number of Eylea® injections and number of patients requiring Eylea® injections for rescue therapy
timeFrame: Up to Week 108
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Associated Retina Consultants, Ltd.
state: Arizona
city: Beverly Hills
country: United States
facility: Retina-Vitreous Associates Medical Group
state: California
city: Irvine
country: United States
facility: University of California, Irvine, The Gavin Herbert Eye Institute
state: California
city: La Jolla
country: United States
facility: Jacobs Retina Center at UCSD
state: California
city: Golden
country: United States
facility: Colorado Retina Associates
state: Colorado
city: Fort Myers
country: United States
facility: Retina Health Center
state: Florida
city: Fort Myers
country: United States
facility: National Ophthalmic Research Institute
state: Florida
city: Winter Haven
country: United States
facility: Center for Retina and Macular Disease
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center, PC
state: Georgia
city: Marietta
country: United States
facility: Georgina Retina, P.C.
state: Georgia
city: Joliet
country: United States
facility: Illinois Retina Associates, S.C.
state: Illinois
city: Oak Park
country: United States
facility: Illinois Retina Associates
state: Illinois
city: Lexington
country: United States
facility: Retina Associates of Kentucky
state: Kentucky
city: Chevy Chase
country: United States
facility: The Retina Group of Washington
state: Maryland
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Consultants, PC
state: Maryland
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan, Kellogg Eye Center
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital-Ophthalmology Research
state: Michigan
city: Chesterfield
country: United States
facility: Lifelong Vision Foundation
state: Missouri
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Bloomfield
country: United States
facility: Retina Center of New Jersey, LLC
state: New Jersey
city: New Brunswick
country: United States
facility: NJ Retina
state: New Jersey
city: Asheville
country: United States
facility: Western Carolina Retinal Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health Eye Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: Retina Northwest, PC
state: Oregon
city: Philadelphia
country: United States
facility: Mid Atlantic Retina
state: Pennsylvania
city: Florence
country: United States
facility: Palmetto Retina Center, LLC
state: South Carolina
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute
state: South Dakota
city: McAllen
country: United States
facility: Valley Retina Institute, PA
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Beer Sheva
country: Israel
facility: Soroka Medical Center
city: Jerusalem
country: Israel
facility: Hadassah-Hebrew University Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Petach-tikva
country: Israel
facility: Rabin Medical Center
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Tel-Aviv
country: Israel
facility: Sourasky Medical Center,
Study officials:
affiliation: Neurotech Pharmaceuticals, Inc.
name: Charles Johnson, MB, ChB
role: STUDY_CHAIR
References: