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NPI-002 Intravitreal Implant for the Delay of Cataract Progression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05026632
Recruitment Status : Recruiting
First Posted : August 30, 2021
Last Update Posted : March 17, 2022
Sponsor:
Information provided by (Responsible Party):
Nacuity Pharmaceuticals, Inc.

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

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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 2022
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

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



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



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (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 diabetic retinopathy, glaucoma, uveitis, or ocular ischemia.
  6. Current smoker
  7. Use of supplemental oxygen
  8. Diabetes
  9. Current lung disease (PU, COPD, Asthma) resulting in decreased oxygen saturation.
  10. Sensitivity to thiol compounds.
  11. Participation in another clinical trial.

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
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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 17, 2022
Last Verified: March 2022
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