Dual Intravitreal Implantation of NT-501 Encapsulated Cell Therapy for Glaucoma
Dual Intravitreal Implantation of NT-501 Encapsulated Cell Therapy for Glaucoma
Brief Summary:
To determine the safety and efficacy over 24 months of dual NT-501 CNTF encapsulated cell therapy (ECT) on visual impairment related to glaucoma.
Detailed Description:
A randomized, sham controlled, masked trial of up to 30 eyes will be recruited into the study. Participants with a qualifying study eye will be randomized after screening and baseline evaluations to receive 2 NT-501 ECT implants in the study eye (20 eyes), 1 NT-501 ECT implant (5 eyes) or a sham surgery (control arm; 5 eyes). No explant will be required. An examination for safety will occur one day and one week following implant and periodically thereafter for 24 months post-implant. Patients in the control arm may be offered 2 NT-501 ECT implants after the 12-month post-operative follow-up visit.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Randomized, Sham Controlled, Masked Phase II Study to Evaluate the Safety and Efficacy of Dual Intravitreal Implantation of NT-501 Encapsulated Cell Therapy for the Treatment of Glaucoma
Actual Study Start Date: May 15, 2021
Estimated Primary Completion Date: August 15, 2023
Estimated Study Completion Date: December 15, 2023
Arm:
- Experimental: Dual Implantation
- Experimental: Single Implantation
- Sham Comparator: Sham Implantation
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 30 |
| Actual Study start date | 15 May 2021 |
| Estimated Study Completion Date | 15 December 2023 |