NPI-002 Intravitreal Implant for the Delay of Cataract Progression
NCT ID: NCT05026632
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2022-01-27
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Single NPI-002 Intravitreal Implant
one NPI-002 implant inserted at the time of vitrectomy
NPI-002 Intravitreal Implant
Implant inserted during vitrectomy.
Double NPI-002 Intravitreal Implant
two NPI-002 implants inserted at the time of vitrectomy
NPI-002 Intravitreal Implant
Implant inserted during vitrectomy.
Control
No implant inserted at time of vitrectomy
No interventions assigned to this group
Interventions
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NPI-002 Intravitreal Implant
Implant inserted during vitrectomy.
Eligibility Criteria
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Inclusion Criteria
2. Natural Lens in place at time of vitrectomy
3. Some cataract present as assessed pre-operatively
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Nacuity Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jami R Kern, PhD
Role: STUDY_DIRECTOR
Nacuity Pharmaceuticals
Locations
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Royal Adelaide Hospital
Adelaide, , Australia
Countries
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Central Contacts
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Facility Contacts
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Kylie Danise
Role: primary
Other Identifiers
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C-21-01
Identifier Type: -
Identifier Source: org_study_id