NPI-002 Intravitreal Implant for the Delay of Cataract Progression

Nacuity Pharmaceuticals

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Cataract

Treatments: Drug: NPI-002 Intravitreal Implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT05026632

C-21-01

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 3 patient groups

Single NPI-002 Intravitreal Implant

Experimental group

Description:

one NPI-002 implant inserted at the time of vitrectomy

Treatment:

Drug: NPI-002 Intravitreal Implant

Double NPI-002 Intravitreal Implant

Experimental group

Description:

two NPI-002 implants inserted at the time of vitrectomy

Treatment:

Drug: NPI-002 Intravitreal Implant

Control

No Intervention group

Description:

No implant inserted at time of vitrectomy