NPI-002 Intravitreal Implant for the Delay of Cataract Progression
Phase 1
Recruiting
- Conditions
- Cataract
- Interventions
- Drug: NPI-002 Intravitreal Implant
- Registration Number
- NCT05026632
- Lead Sponsor
- Nacuity Pharmaceuticals, Inc.
- Brief Summary
This study will examine the safety and efficacy NPI-002 intravitreal implants post vitrectomy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Indicated for vitrectomy
- Natural Lens in place at time of vitrectomy
- Some cataract present as assessed pre-operatively
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Exclusion Criteria
- 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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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Double NPI-002 Intravitreal Implant NPI-002 Intravitreal Implant two NPI-002 implants inserted at the time of vitrectomy Single NPI-002 Intravitreal Implant NPI-002 Intravitreal Implant one NPI-002 implant inserted at the time of vitrectomy
- Primary Outcome Measures
Name Time Method Lens Densitometry 6 months Change from Baseline
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Royal Adelaide Hospital
🇦🇺Adelaide, Australia