Non-proliferative Diabetic RetinopathyPhase 1NCT05695417
Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI in Subjects With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy
A Phase 1 study testing OTX-TKI in people with Non-proliferative Diabetic Retinopathy, run by Ocular Therapeutix, Inc. at 10 sites in United States.
Trial summary
Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI in Subjects with Moderately Severe to Severe Non-proliferative Diabetic Retinopathy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-proliferative Diabetic Retinopathy
- What is being tested?
- OTX-TKI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 10 sitesUnited States
- Study dates
- 15 Jan 2023to Dec 2024
- Phase
- Phase 1
- 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
- Are at least 18 years of age or older
- Moderately severe to severe NPDR in the study eye defined as: DRSS levels of 47 or 53 as determined by the reading center
- Diabetes type 1 or 2
- BCVA ETDRS letter score in the study eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better)
Who cannot join
- DME within 6 months involving the center of the macula in the study eye
- Presence of DME threatening the center (within 200 microns) of the macula in the study eye
- OCT CSFT of ≥320 μm in the study eye
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Ocular Therapeutix, Inc.
Augusta, Georgia, 30909
Ocular Therapeutiux, Inc.
Austin, Texas, 78750
Ocular Therapeutix, Inc.
Bakersfield, California, 93308
Ocular Therapeutix Inc
Bellaire, Texas, 77401
Ocular Therapeutix, Inc.
Hagerstown, Maryland, 21740
Ocular Therapeutix, Inc.
Lemont, Illinois, 60439
Ocular Therapeutix Inc
Phoenix, Arizona, 85053
Ocular Therapeutix, Inc.
Reno, Nevada, 89502
Ocular Therapeutix, Inc
San Antonio, Texas, 78211
Ocular Therapeutix Inc.
The Woodlands, Texas, 77384
About this study
Official title: A Phase 1B, Multicenter, Double-Masked, Randomized, Parallel Group Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI (Axitinib Implant) for Intravitreal Injection in Subjects With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy
Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI in Subjects with Moderately Severe to Severe Non-proliferative Diabetic Retinopathy
Read the detailed description
Multicenter, Double-Masked, Randomized, Parallel Group Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI (axitinib implant) for Intravitreal Injection in Subjects with Moderately Severe to Severe Non-proliferative Diabetic Retinopathy
- Conditions
- Non-proliferative Diabetic Retinopathy
- Being tested
- OTX-TKI, Sham
- Keywords
- Nonproliferative diabetic retinopathy, Diabetic retinopathy OTX-TKI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTX-TKIDrug
Injection of OTX-TKI
ShamDrug
Sham Injection of OTX-TKI
| Study group | Role | What they receive |
|---|---|---|
| OTX-TKI | Active comparator | Not described Receives: Drug: OTX-TKI |
| Sham | Sham comparator | Not described Receives: Drug: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Frequency of treatment emergent adverse events
Measured: Baseline up to Week 52
Secondary outcomes (4)
Change in Best Corrected Visual Acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score
Best Corrected Visual Acuity (BCVA) changes from baseline
Measured: Baseline up to Week 52
Central subfield thickness changes
Central subfield thickness changes from baseline
Measured: Baseline up to Week 52
Rescue Therapy
Proportion of subjects receiving rescue therapy
Measured: Baseline up to Week 52
Diabetic Retinopathy Severity Scale (DRSS) changes
Diabetic Retinopathy Severity Scale (DRSS) changes from baseline
Measured: Baseline up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start15 Jan 2023
- Primary completionJan 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-proliferative Diabetic RetinopathyStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2:1
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ocular Therapeutix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05695417
- Sponsor's protocol ID
- OTX-TKI-2022-101
- Status last verified
- Dec 2023
- First submitted
- 5 Jan 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1B, Multicenter, Double-Masked, Randomized, Parallel Group Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI (Axitinib Implant) for Intravitreal Injection in Subjects With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT05695417
- Acronym / sponsor ID
- OTX-TKI-2022-101
- Conditions
- Non-proliferative Diabetic Retinopathy
- Keywords
- Nonproliferative diabetic retinopathy, Diabetic retinopathy OTX-TKI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Ocular Therapeutix, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 25 Jan 2023 (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.
Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI in Subjects with Moderately Severe to Severe Non-proliferative Diabetic Retinopathy
Detailed description
Multicenter, Double-Masked, Randomized, Parallel Group Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI (axitinib implant) for Intravitreal Injection in Subjects with Moderately Severe to Severe Non-proliferative Diabetic Retinopathy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 2:1
| Arm | Type | Receives |
|---|---|---|
| OTX-TKI | Active comparator | Drug: OTX-TKI |
| Sham | Sham comparator | Drug: Sham |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Are at least 18 years of age or older
- Moderately severe to severe NPDR in the study eye defined as: DRSS levels of 47 or 53 as determined by the reading center
- Diabetes type 1 or 2
- BCVA ETDRS letter score in the study eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better)
Key exclusion criteria (3 listed)
- DME within 6 months involving the center of the macula in the study eye
- Presence of DME threatening the center (within 200 microns) of the macula in the study eye
- OCT CSFT of ≥320 μm in the study eye
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 |
|---|---|---|
| OTX-TKIInjection of OTX-TKI | Drug | OTX-TKI |
| ShamSham Injection of OTX-TKI | Drug | Sham |
Primary outcome
Safety and Tolerability
Time frame: Baseline up to Week 52
Frequency of treatment emergent adverse events
4 secondary outcomes
Change in Best Corrected Visual Acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score
Time frame: Baseline up to Week 52
Central subfield thickness changes
Time frame: Baseline up to Week 52
Rescue Therapy
Time frame: Baseline up to Week 52
Diabetic Retinopathy Severity Scale (DRSS) changes
Time frame: Baseline up to Week 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OTX-TKI in people with Non-proliferative Diabetic Retinopathy, run by Ocular Therapeutix, Inc. at 10 sites in United States.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Safety and Tolerability (time frame: Baseline up to Week 52). 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 8 Dec 2023.