Cataract Clinical Trial
Official title:
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.
| Status | Recruiting |
| Enrollment | 30 |
| Est. completion date | February 2025 |
| Est. primary completion date | October 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Royal Adelaide Hospital | Adelaide |
| Lead Sponsor | Collaborator |
|---|---|
| Nacuity Pharmaceuticals, Inc. |
Australia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Lens Densitometry | Change from Baseline | 6 months |
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