RecruitingPhase 1Phase 2NCT05026632
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
Sponsor
Nacuity Pharmaceuticals, Inc.
Enrollment
30 participants
Start Date
Jan 27, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
This study will examine the safety and efficacy NPI-002 intravitreal implants post vitrectomy.
Eligibility
Min Age: 18 Years
Inclusion Criteria3
- Indicated for vitrectomy
- Natural Lens in place at time of vitrectomy
- Some cataract present as assessed pre-operatively
Exclusion Criteria11
- 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.
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Interventions
DRUGNPI-002 Intravitreal Implant
Implant inserted during vitrectomy.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05026632
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