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Trial record 1 of 1 for:    NCT05026632
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NPI-002 Intravitreal Implant for the Delay of Cataract Progression

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ClinicalTrials.gov Identifier: NCT05026632
Recruitment Status : Recruiting
First Posted : August 30, 2021
Last Update Posted : March 21, 2023
Sponsor:
Information provided by (Responsible Party):
Nacuity Pharmaceuticals, Inc.

Study Description
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Brief Summary:
This study will examine the safety and efficacy NPI-002 intravitreal implants post vitrectomy.

Condition or disease Intervention/treatment Phase
Cataract Drug: NPI-002 Intravitreal Implant Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Efficacy of NPI-002 Intravitreal Implant for the Delay of Cataract Progression in Patients Undergoing Vitrectomy
Actual Study Start Date : January 27, 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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Arm Intervention/treatment
Experimental: Single NPI-002 Intravitreal Implant
one NPI-002 implant inserted at the time of vitrectomy
 Drug: NPI-002 Intravitreal Implant
Implant inserted during vitrectomy.
Experimental: Double NPI-002 Intravitreal Implant
two NPI-002 implants inserted at the time of vitrectomy
 Drug: NPI-002 Intravitreal Implant
Implant inserted during vitrectomy.
No Intervention: Control
No implant inserted at time of vitrectomy


Outcome Measures
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Primary Outcome Measures :
  1. Lens Densitometry [ Time Frame: 6 months ]
    Change from Baseline


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05026632


Contacts
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Contact: Jami R Kern, PhD 817-291-4232 jami@nacuity.com

Locations
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Australia
Royal Adelaide Hospital Recruiting
Adelaide, Australia
Contact: Kylie Danise         
Sponsors and Collaborators
Nacuity Pharmaceuticals, Inc.
Investigators
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Study Director: Jami R Kern, PhD Nacuity Pharmaceuticals
More Information
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Responsible Party: Nacuity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT05026632    
Other Study ID Numbers: C-21-01
First Posted: August 30, 2021    Key Record Dates
Last Update Posted: March 21, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases