NPI-002 Intravitreal Implant for the Delay of Cataract Progression

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

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05026632

Enrollment

Registered

2021-08-30

Start date

2022-01-27

Completion date

2026-09-01

Last updated

2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Brief summary

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

Interventions

DRUGNPI-002 Intravitreal Implant

Implant inserted during vitrectomy.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Lens Densitometry	6 months	Change from Baseline

Countries

Australia

Contacts

STUDY_DIRECTORJami R Kern, PhD

Nacuity Pharmaceuticals

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026