Back to resultsNPI-002 Intravitreal Implant for the Delay of Cataract Progression
Primary Purpose
Cataract
Status
Recruiting
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
NPI-002 Intravitreal Implant
Sponsored by
About this trial
This is an interventional prevention trial for Cataract
Eligibility Criteria
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.
Sites / Locations
- Royal Adelaide HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Single NPI-002 Intravitreal Implant
Double NPI-002 Intravitreal Implant
Control
Arm Description
one NPI-002 implant inserted at the time of vitrectomy
two NPI-002 implants inserted at the time of vitrectomy
No implant inserted at time of vitrectomy
Outcomes
Primary Outcome Measures
Lens Densitometry
Change from Baseline
Secondary Outcome Measures
Full Information
NCT ID
NCT05026632
First Posted
August 24, 2021
Last Updated
March 17, 2023
Sponsor
Nacuity Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05026632
Brief Title
NPI-002 Intravitreal Implant for the Delay of Cataract Progression
Official Title
Safety and Efficacy of NPI-002 Intravitreal Implant for the Delay of Cataract Progression in Patients Undergoing Vitrectomy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 27, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nacuity Pharmaceuticals, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will examine the safety and efficacy NPI-002 intravitreal implants post vitrectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single NPI-002 Intravitreal Implant
Arm Type
Experimental
Arm Description
one NPI-002 implant inserted at the time of vitrectomy
Arm Title
Double NPI-002 Intravitreal Implant
Arm Type
Experimental
Arm Description
two NPI-002 implants inserted at the time of vitrectomy
Arm Title
Control
Arm Type
No Intervention
Arm Description
No implant inserted at time of vitrectomy
Intervention Type
Drug
Intervention Name(s)
NPI-002 Intravitreal Implant
Intervention Description
Implant inserted during vitrectomy.
Primary Outcome Measure Information:
Title
Lens Densitometry
Description
Change from Baseline
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jami R Kern, PhD
Phone
817-291-4232
Email
jami@nacuity.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jami R Kern, PhD
Organizational Affiliation
Nacuity Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Royal Adelaide Hospital
City
Adelaide
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kylie Danise
12. IPD Sharing Statement
Plan to Share IPD
No
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NPI-002 Intravitreal Implant for the Delay of Cataract Progression
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