CataractPhase 1/2NCT05026632
NPI-002 Intravitreal Implant for the Delay of Cataract Progression
A Phase 1/2 study testing NPI-002 Intravitreal Implant in people with Cataract, run by Nacuity Pharmaceuticals, Inc. at 1 site in Australia.
Trial summary
This study will examine the safety and efficacy NPI-002 intravitreal implants post vitrectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- NPI-002 Intravitreal Implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteAustralia
- Study dates
- 27 Jan 2022to 3 Sep 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indicated for vitrectomy
- Natural Lens in place at time of vitrectomy
- Some cataract present as assessed pre-operatively
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cataract
- Being tested
- NPI-002 Intravitreal Implant
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPI-002 Intravitreal ImplantDrug
Implant inserted during vitrectomy.
| Study group | Role | What they receive |
|---|---|---|
| Single NPI-002 Intravitreal Implant | Experimental | one NPI-002 implant inserted at the time of vitrectomy Receives: Drug: NPI-002 Intravitreal Implant |
| Double NPI-002 Intravitreal Implant | Experimental | two NPI-002 implants inserted at the time of vitrectomy Receives: Drug: NPI-002 Intravitreal Implant |
| Control | No intervention | No implant inserted at time of vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lens Densitometry
Change from Baseline
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start27 Jan 2022
- Primary completion3 Sep 2026
- Study completion3 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nacuity Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jami R Kern, PhD, Study director, Nacuity Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026632
- Sponsor's protocol ID
- C-21-01
- Status last verified
- Oct 2026
- First submitted
- 24 Aug 2021
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of NPI-002 Intravitreal Implant for the Delay of Cataract Progression in Patients Undergoing Vitrectomy
- ClinicalTrials.gov ID
- NCT05026632
- Acronym / sponsor ID
- C-21-01
- Conditions
- Cataract
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Nacuity Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Jan 2022 (actual)
- Primary completion
- 3 Sep 2026 (actual)
- Study completion
- 3 Sep 2026 (actual)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine the safety and efficacy NPI-002 intravitreal implants post vitrectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single NPI-002 Intravitreal Implant | Experimental | Drug: NPI-002 Intravitreal Implantone NPI-002 implant inserted at the time of vitrectomy |
| Double NPI-002 Intravitreal Implant | Experimental | Drug: NPI-002 Intravitreal Implanttwo NPI-002 implants inserted at the time of vitrectomy |
| Control | No intervention | –No implant inserted at time of vitrectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Indicated for vitrectomy
- Natural Lens in place at time of vitrectomy
- Some cataract present as assessed pre-operatively
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NPI-002 Intravitreal ImplantImplant inserted during vitrectomy. | Drug | Double NPI-002 Intravitreal Implant, Single NPI-002 Intravitreal Implant |
Primary outcome
Lens Densitometry
Time frame: 6 months
Change from Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jami R Kern, PhD study director
Nacuity Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NPI-002 Intravitreal Implant in people with Cataract, run by Nacuity Pharmaceuticals, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lens Densitometry (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.