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 |
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Recruitment Status :
Terminated
First Posted : August 29, 2014
Last Update Posted : November 16, 2016
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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 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 |
| 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 |
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Active Comparator: Eylea® injected intravitreally every 8 weeks
Eylea® injected intravitreally every 8 weeks
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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. |
- Percentage of patients with less than a 3-line loss of BCVA in ETDRS letters [ Time Frame: Week 52 and Week 108 ]
- 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 ]
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| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
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| Study Chair: | Charles Johnson, MB, ChB | Neurotech Pharmaceuticals, Inc. |
| 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:
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Wet AMD Wet Age Related Macular Degeneration Recurrent CNV Secondary to AMD Active subfoveal CNV |
Additional relevant MeSH terms:
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Macular Degeneration Choroidal Neovascularization Retinal Degeneration Retinal Diseases Eye Diseases |
Choroid Diseases Uveal Diseases Neovascularization, Pathologic Metaplasia Pathologic Processes |