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NPI-002 Intravitreal Implant for the Delay of Cataract Progression

Sponsor
Nacuity Pharmaceuticals, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05026632
Collaborator
(none)
30
Enrollment
1
Location
3
Arms
12.2
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will examine the safety and efficacy NPI-002 intravitreal implants post vitrectomy.

Condition or Disease Intervention/Treatment Phase
  • Drug: NPI-002 Intravitreal Implant
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Safety and Efficacy of NPI-002 Intravitreal Implant for the Delay of Cataract Progression in Patients Undergoing Vitrectomy
Actual Study Start Date :
Jan 27, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Single NPI-002 Intravitreal Implant

one NPI-002 implant inserted at the time of vitrectomy

Drug: NPI-002 Intravitreal Implant
Implant inserted during vitrectomy.
Experimental: Double NPI-002 Intravitreal Implant

two NPI-002 implants inserted at the time of vitrectomy

Drug: NPI-002 Intravitreal Implant
Implant inserted during vitrectomy.
No Intervention: Control

No implant inserted at time of vitrectomy

Outcome Measures

Primary Outcome Measures

  1. Lens Densitometry [6 months]

    Change from Baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Indicated for vitrectomy

  2. Natural Lens in place at time of vitrectomy

  3. Some cataract present as assessed pre-operatively

Exclusion Criteria:

  1. Previous intraocular surgery in study eye

  2. Clear zonular weakness or defects / coloboma

  3. Not on stable dose of medications for other conditions.

  4. Need for oral corticosteroids during study participation.

  5. Evidence or history of diabetic retinopathy, glaucoma, uveitis, or ocular ischemia.

  6. Current smoker

  7. Use of supplemental oxygen

  8. Diabetes

  9. Current lung disease (PU, COPD, Asthma) resulting in decreased oxygen saturation.

  10. Sensitivity to thiol compounds.

  11. Participation in another clinical trial.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Royal Adelaide Hospital Adelaide Australia

Sponsors and Collaborators

  • Nacuity Pharmaceuticals, Inc.

Investigators

  • Study Director: Jami R Kern, PhD, Nacuity Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nacuity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT05026632
Other Study ID Numbers:
  • C-21-01
First Posted:
Aug 30, 2021
Last Update Posted:
Mar 17, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cataract

Study Results

No Results Posted as of Mar 17, 2022