NPI-002 Intravitreal Implant for the Delay of Cataract Progression

April 8, 2026 updated by: Nacuity Pharmaceuticals, Inc.

Safety and Efficacy of NPI-002 Intravitreal Implant for the Delay of Cataract Progression in Patients Undergoing Vitrectomy

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia
        • Royal Adelaide Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 uveitis, or ocular ischemia.
  6. Current smoker
  7. Use of supplemental oxygen
  8. Evidence or history of proliferative diabetic retinopathy.
  9. Current lung disease (PU, COPD, Asthma) resulting in decreased oxygen saturation.
  10. Sensitivity to thiol compounds.
  11. Participation in another clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lens Densitometry
Time Frame: 6 months
Change from Baseline
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nacuity Pharmaceuticals, Inc.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2022

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

August 24, 2021

First Submitted That Met QC Criteria

August 24, 2021

First Posted (Actual)

August 30, 2021

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-21-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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