Study of the Intravitreal Implantation of NT-503-3 Encaps... | NCT02228304

Studies
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)

NCT02228304

Sponsor

Neurotech Pharmaceuticals

Status

Terminated

Last Update Posted

Jul 18, 2022Actual

Enrollment

42Actual

Phase

Phase 1Phase 2

Conditions

Macular Degeneration

Interventions

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

Countries

United States
Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

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

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

After enrolling approximately 1/2 of the trial participants, the rescues exceeded stopping criteria.

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Apr 2016Actual

Completion Date

Apr 2016Actual

First Submitted Date

Aug 27, 2014

First Submission Date that Met QC Criteria

Aug 28, 2014

First Posted Date

Aug 29, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Nov 15, 2016

Certification/Extension First Submitted that Passed QC Review

Nov 15, 2016

Certification/Extension First Posted Date

Nov 16, 2016Estimated

Last Update Submitted Date

Jul 14, 2022

Last Update Posted Date

Jul 18, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NT-503-3 ECT implantation	Experimental		Drug: NT-503-3 ECT implantation
Eylea® injected intravitreally every 8 weeks	Active Comparator	Eylea® injected intravitreally every 8 weeks	Drug: Eylea® injected intravitreally administered every 8 weeks

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NT-503-3 ECT implantation	Drug	NT-503-3 ECT implantation is a biological sustained drug delivery device that could provide continuous delivery of an anti-VEGF therapy	NT-503-3 ECT implantation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in best corrected visual acuity (BCVA)		Week 52
Change from baseline in macular thickness as determined by Spectral Domain Optical Coherence Tomography (sdOCT)		Up to Week 108

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Charles Johnson, MB, ChB	Neurotech Pharmaceuticals, Inc.	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Associated Retina Consultants, Ltd.		Phoenix	Arizona	85020	United States
Retina-Vitreous Associates Medical Group

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases