NCT05026632

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
4mo left

Started Jan 2022

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Jan 2022Sep 2026

First Submitted

Initial submission to the registry

August 24, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 30, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

January 27, 2022

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

April 13, 2026

Status Verified

December 1, 2025

Enrollment Period

4.6 years

First QC Date

August 24, 2021

Last Update Submit

April 8, 2026

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

  • Lens Densitometry

    Change from Baseline

    6 months

Study Arms (3)

Single NPI-002 Intravitreal Implant

EXPERIMENTAL

one NPI-002 implant inserted at the time of vitrectomy

Drug: NPI-002 Intravitreal Implant

Double NPI-002 Intravitreal Implant

EXPERIMENTAL

two NPI-002 implants inserted at the time of vitrectomy

Drug: NPI-002 Intravitreal Implant

Control

NO INTERVENTION

No implant inserted at time of vitrectomy

Interventions

NPI-002 Intravitreal ImplantDRUG

Implant inserted during vitrectomy.

Double NPI-002 Intravitreal ImplantSingle NPI-002 Intravitreal Implant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Indicated for vitrectomy
  • Natural Lens in place at time of vitrectomy
  • Some cataract present as assessed pre-operatively

You may not qualify if:

  • Previous intraocular surgery in study eye.
  • Clear zonular weakness or defects / coloboma.
  • Not on stable dose of medications for other conditions.
  • Need for oral corticosteroids during study participation.
  • Evidence or history of uveitis, or ocular ischemia.
  • Current smoker
  • Use of supplemental oxygen
  • Evidence or history of proliferative diabetic retinopathy.
  • Current lung disease (PU, COPD, Asthma) resulting in decreased oxygen saturation.
  • Sensitivity to thiol compounds.
  • Participation in another clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Adelaide Hospital

Adelaide, Australia

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Jami R Kern, PhD

    Nacuity Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2021

First Posted

August 30, 2021

Study Start

January 27, 2022

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

April 13, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)