NPI-002 Intravitreal Implant for the Delay of Cataract Progression

Sponsor
Nacuity Pharmaceuticals, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05026632
Collaborator
(none)
30
Enrollment
3
Arms
11
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or DiseaseIntervention/TreatmentPhase
  • 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
Anticipated Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Single NPI-002 Intravitreal Implant

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

Experimental: Double NPI-002 Intravitreal Implant

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

No Intervention: Control

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

No locations specified.

Sponsors and Collaborators

  • Nacuity Pharmaceuticals, Inc.

Investigators

None specified.

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:
Aug 30, 2021
Last Verified:
Aug 1, 2021
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:

Study Results

No Results Posted as of Aug 30, 2021