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)

Description

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

Study Start Date

September 2014

Estimated Completion Date

March 2018

Interventions

  • Drug: Eylea® injected intravitreally administered every 8 weeks
  • Drug: NT-503-3 ECT implantation
  • Drug: Eylea® injected intravitreally administered every 8 weeks

Specialties

  • Ophthalmology: Retina
  • Physician Assistant: Ophthalmology

MeSH Terms

  • Choroidal Neovascularization
  • Eye Diseases
  • Macular Degeneration
  • Retinal Degeneration

Study ID

Neurotech Pharmaceuticals -- NT-503-3-AMD-001

Status

Unknown

Trial ID

NCT02228304

Study Type

Interventional

Trial Phase

Phase 1/Phase 2

Enrollment Quota

170

Sponsor

Neurotech Pharmaceuticals

Key

Inclusion Criteria

  • Diagnosis of Active (recurrent or persistent) subfoveal CNV lesions secondary to AMD in one eye
  • Prior Intravitreal Anti-VEGF injections Key

Exclusion Criteria

  • Significant subretinal hemorrhage
  • Significant Scar and/or, fibrosis
  • Suspected retinal angiomatous proliferation (RAP) or polypoidal choroidopathy, or pigment epithelial tears or rips

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (32)

Study Location Distance Name Phone Email
Ophthalmic Consultants of Boston - Boston, Massachusetts 2.8 miles Jeffrey S Heier MD 617-367-4800 jsheier@eyeboston.com
Retina Center of New Jersey LLC - Bloomfield, New Jersey 192.8 miles Patrick Higgins MD 973-707-5632 drhiggins@retinacenternj.com
NJ Retina - New Brunswick, New Jersey 217.0 miles Daniel B Roth MD None rothretina@gmail.com
Mid Atlantic Retina - Philadelphia, Pennsylvania 269.5 miles Allen Ho MD 215-928-3095 acho@att.net
The Retina Group of Washington - Chevy Chase, Maryland 391.7 miles Michael M Lai MD 301-656-8100 mikemlai@yahoo.com
Cumberland Valley Retina Consultants PC - Hagerstown, Maryland 393.7 miles Allen Y Hu MD 310-467-4592 AllenHu0130@gmail.com
Cleveland Clinic - Cleveland, Ohio 544.9 miles Rishi Singh MD 216-445-9497 drrishisingh@gmail.com
William Beaumont HospitalOphthalmology Research - Royal Oak, Michigan 616.2 miles George A Williams MD 248-551-2175 gwilliams@beaumont.edu
University of Michigan Kellogg Eye Center - Ann Arbor, Michigan 644.6 miles Grant Comer MD None None
Wake Forest Baptist Health Eye Center - Winston-Salem, North Carolina 659.2 miles Craig Greven MD 336-716-4091 cgreven@wakehealth.edu
Palmetto Retina Center LLC - Florence, South Carolina 736.8 miles W Lloyd Clark MD 803-931-0077 lclark@palmettoretina.com
Retina Associates of Kentucky - Lexington, Kentucky 765.5 miles Thomas W Stone MD 859-263-3900 drstone@retinaky.com
Western Carolina Retinal Associates - Asheville, North Carolina 774.5 miles William Z Bridges Jr MD 828-255-8008 None
Illinois Retina Associates - Oak Park, Illinois 856.7 miles Mathew W MacCumber MD PhD 773-871-8444 macretina@aol.com
Southeast Retina Center PC - Augusta, Georgia 857.6 miles Dennis M Marcus MD 706-650-0061 dmarcus@southeastretina.com
Medical College of Wisconsin - Milwaukee, Wisconsin 862.1 miles David Weinberg MD 414-456-7840 dweinber@mcw.edu
Illinois Retina Associates SC - Joliet, Illinois 876.5 miles John S Pollack MD 815-744-7515 pollackjs@aol.com
Georgina Retina PC - Marietta, Georgia 933.9 miles Robert Stoltz MD PhD 404-299-5209 stoltz.robert@gmail.com
Lifelong Vision Foundation - Chesterfield, Missouri 1,053.3 miles Nancy Holekamp MD 636-728-0111 None
Center for Retina and Macular Disease - Winter Haven, Florida 1,161.3 miles Michael Tolentino MD 863-297-5400 miket@crmd.net
Retina Health Center - Ft. Myers, Florida 1,253.5 miles Alexander M Eaton MD 239-337-3337 None
National Ophthalmic Research Institute - Ft. Myers, Florida 1,255.3 miles Paul A Raskauskas MD 239-938-1284 PARnori@eye.md
Black Hills Regional Eye Institute - Rapid City, South Dakota 1,612.9 miles Prema Abraham MD 605-341-2000 retina@bhrei.com
Medical Center Ophthalmology Associates - San Antonio, Texas 1,769.8 miles Michael A Singer MD None msinger1@earthlink.net
Colorado Retina Associates - Golden, Colorado 1,779.3 miles Brian Joondeph MD None bjoondeph@retinacolorado.com
Valley Retina Institute PA - McAllen, Texas 1,902.3 miles Victor H Gonzalez MD 956-631-8875 None
Associated Retina Consultants Ltd - Phoenix, Arizona 2,294.3 miles Alan Gordon MD None None
Sierra Eye Associates - Reno, Nevada 2,519.5 miles Arshad Khanani MD 775-329-0286 None
Retina Northwest PC - Portland, Oregon 2,538.8 miles Michael S Lee MD None None
Jacobs Retina Center at UCSD - La Jolla, California 2,581.5 miles William R Freeman MD 858-822-3170 None
University of California Irvine The Gavin Herbert Eye Institute - Irvine, California 2,587.5 miles Baruch D Kuppermann MD PhD 949-824-6256 bdkupper@uci.edu
RetinaVitreous Associates Medical Group - Beverly Hills, California 2,601.9 miles David Boyer MD 310-854-6201 None

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