- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05026632
NPI-002 Intravitreal Implant for the Delay of Cataract Progression
February 7, 2024 updated by: Nacuity Pharmaceuticals, Inc.
Safety and Efficacy of NPI-002 Intravitreal Implant for the Delay of Cataract Progression in Patients Undergoing Vitrectomy
This study will examine the safety and efficacy NPI-002 intravitreal implants post vitrectomy.
Study Overview
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jami R Kern, PhD
- Phone Number: 817-291-4232
- Email: jami@nacuity.com
Study Locations
-
-
-
Adelaide, Australia
- Recruiting
- Royal Adelaide Hospital
-
Contact:
- Kylie Danise
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Indicated for vitrectomy
- Natural Lens in place at time of vitrectomy
- Some cataract present as assessed pre-operatively
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single NPI-002 Intravitreal Implant
one NPI-002 implant inserted at the time of vitrectomy
|
Implant inserted during vitrectomy.
|
Experimental: Double NPI-002 Intravitreal Implant
two NPI-002 implants inserted at the time of vitrectomy
|
Implant inserted during vitrectomy.
|
No Intervention: Control
No implant inserted at time of vitrectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lens Densitometry
Time Frame: 6 months
|
Change from Baseline
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jami R Kern, PhD, Nacuity Pharmaceuticals
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 27, 2022
Primary Completion (Estimated)
October 1, 2024
Study Completion (Estimated)
February 1, 2025
Study Registration Dates
First Submitted
August 24, 2021
First Submitted That Met QC Criteria
August 24, 2021
First Posted (Actual)
August 30, 2021
Study Record Updates
Last Update Posted (Actual)
February 8, 2024
Last Update Submitted That Met QC Criteria
February 7, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C-21-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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