NPI-002 implant to slow cataract progression after vitrectomy
Safety and Efficacy of NPI-002 Intravitreal Implant for the Delay of Cataract Progression in Patients Undergoing Vitrectomy
This study is testing whether the NPI-002 implant can help slow down cataract progression in people who are having vitrectomy surgery.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nacuity Pharmaceuticals, Inc. Industry-sponsored |
| Locations | 1 site (Adelaide) |
| Trial ID | NCT05026632 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of the NPI-002 intravitreal implant in patients undergoing vitrectomy who have cataracts. Participants will receive the implant to determine its impact on delaying cataract progression. The study is designed to assess both the short-term and long-term outcomes of this intervention. It aims to provide insights into a new approach for managing cataracts in patients who require vitrectomy.
Who should consider this trial
Good fit: Ideal candidates are individuals scheduled for vitrectomy who have a natural lens and some degree of cataract present.
Not a fit: Patients who have had previous intraocular surgery in the study eye or those with certain ocular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly delay the progression of cataracts in patients undergoing vitrectomy, potentially improving their vision and quality of life.
How similar studies have performed: While this approach is novel, similar studies exploring intravitreal implants for ocular conditions have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Adelaide
- Royal Adelaide Hospital — Adelaide, Australia (Recruiting)
Study contacts
- Study coordinator: Jami R Kern, PhD
- Email: jami@nacuity.com
- Phone: 817-291-4232
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.