RECRUITINGPhase 1 / Phase 2INTERVENTIONAL
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
About This Trial
This study will examine the safety and efficacy NPI-002 intravitreal implants post vitrectomy.
Who May Be Eligible (Plain English)
Who May Qualify:
1. Indicated for vitrectomy
2. Natural Lens in place at time of vitrectomy
3. Some cataract present as assessed pre-operatively
Who Should NOT Join This Trial:
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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
NPI-002 Intravitreal Implant
Implant inserted during vitrectomy.
Locations (1)
Royal Adelaide Hospital
Adelaide, Australia