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)

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ClinicalTrials.gov Identifier: NCT02228304

Recruitment Status : Terminated

First Posted : August 29, 2014

Last Update Posted : November 16, 2016

Sponsor:

Information provided by (Responsible Party):

Neurotech Pharmaceuticals

Study Description

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

Condition or disease	Intervention/treatment	Phase
Macular Degeneration	Drug: NT-503-3 ECT implantation Drug: Eylea® injected intravitreally administered every 8 weeks	Phase 1 Phase 2

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	42 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:	Treatment
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 Start Date :	September 2014
Actual Primary Completion Date :	April 2016
Actual Study Completion Date :	April 2016

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Age-related macular degeneration

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Aflibercept Ziv-aflibercept

Genetic and Rare Diseases Information Center resources: Uveal Diseases

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: NT-503-3 ECT implantation	Drug: NT-503-3 ECT implantation NT-503-3 ECT implantation is a biological sustained drug delivery device that could provide continuous delivery of an anti-VEGF therapy
Active Comparator: Eylea® injected intravitreally every 8 weeks Eylea® injected intravitreally every 8 weeks	Drug: Eylea® injected intravitreally administered every 8 weeks The first part, stage 1, Phase I is open label with the experimental treatment arm only. Eylea® injected intravitreally is only used as a comparator in the stage 2, Phase II, portion of the study.

Outcome Measures

Primary Outcome Measures :

Percentage of patients with less than a 3-line loss of BCVA in ETDRS letters [ Time Frame: Week 52 and Week 108 ]

Secondary Outcome Measures :

Change from baseline in best corrected visual acuity (BCVA) [ Time Frame: Week 52 ]
Change from baseline in macular thickness as determined by Spectral Domain Optical Coherence Tomography (sdOCT) [ Time Frame: Up to Week 108 ]
Mean (median) number of Eylea® injections and number of patients requiring Eylea® injections for rescue therapy [ Time Frame: Up to Week 108 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	50 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228304

Show 38 Study Locations

Sponsors and Collaborators

Neurotech Pharmaceuticals

Investigators


Study Chair:	Charles Johnson, MB, ChB	Neurotech Pharmaceuticals, Inc.

More Information


Responsible Party:	Neurotech Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT02228304 History of Changes
Other Study ID Numbers:	NT-503-3-AMD-001
First Posted:	August 29, 2014 Key Record Dates
Last Update Posted:	November 16, 2016
Last Verified:	November 2016

Keywords provided by Neurotech Pharmaceuticals:


Wet AMD Wet Age Related Macular Degeneration Recurrent CNV Secondary to AMD Active subfoveal CNV

Additional relevant MeSH terms:


Macular Degeneration Choroidal Neovascularization Retinal Degeneration Retinal Diseases Eye Diseases	Choroid Diseases Uveal Diseases Neovascularization, Pathologic Metaplasia Pathologic Processes

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