Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05026632




Registration number
NCT05026632
Ethics application status
Date submitted
24/08/2021
Date registered
30/08/2021
Date last updated
8/02/2024

Titles & IDs
Public title
NPI-002 Intravitreal Implant for the Delay of Cataract Progression
Scientific title
Safety and Efficacy of NPI-002 Intravitreal Implant for the Delay of Cataract Progression in Patients Undergoing Vitrectomy
Secondary ID [1] 0 0
C-21-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cataract 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - NPI-002 Intravitreal Implant

Experimental: Single NPI-002 Intravitreal Implant - one NPI-002 implant inserted at the time of vitrectomy

Experimental: Double NPI-002 Intravitreal Implant - two NPI-002 implants inserted at the time of vitrectomy

No Intervention: Control - No implant inserted at time of vitrectomy


Treatment: Drugs: NPI-002 Intravitreal Implant
Implant inserted during vitrectomy.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Lens Densitometry
Timepoint [1] 0 0
6 months

Eligibility
Key inclusion criteria
1. Indicated for vitrectomy

2. Natural Lens in place at time of vitrectomy

3. Some cataract present as assessed pre-operatively
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/01/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Nacuity Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will examine the safety and efficacy NPI-002 intravitreal implants post
vitrectomy.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05026632
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jami R Kern, PhD
Address 0 0
Nacuity Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jami R Kern, PhD
Address 0 0
Country 0 0
Phone 0 0
817-291-4232
Fax 0 0
Email 0 0
jami@nacuity.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05026632