Neovascular Age-Related Macular DegenerationPhase 1NCT04989699
Study Evaluating the Treatment of OTX-TKI for Subjects With Neovascular Age-related Macular Degeneration
A Phase 1 study of Neovascular Age-Related Macular Degeneration, run by Ocular Therapeutix, Inc. at 6 sites in United States.
Trial summary
Evaluate the safety, tolerability, and efficacy of OTX-TKI for intravitreal use in subjects with Neovascular Age-Related Macular Degeneration Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-Related Macular Degeneration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 6 sitesUnited States
- Study dates
- 28 Jul 2021to 18 Dec 2023
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a diagnosis, within 3 years of screening, of previously treated subfoveal neovascularization (SFNV) secondary to nAMD with leakage involving the fovea, previously treated with documented evidence of an initially favorable clinical response to anti-VEGF therapy (i.e. aflibercept, ranibizumab, brolucizumab, or bevacizumab).
- The macular appearance on OCT is considered to be free of excess intraretinal and/or subretinal fluid as judged by the investigator.
- Must have received at least 3 anti-VEGF injections in the past year.
- Have received the most recent anti-VEGF injection within the past 1-4 weeks prior to screening visit.
- BCVA ETDRS score between 24 and 83 letters (~20/25 to ~20/320 Snellen equivalent)
Who cannot join
- Have evidence of a scar, fibrosis or atrophy of >50% of the total lesion in the study eye
- Have presence of a disease other than choroidal neovascular membrane (CNVM) due to AMD in the study eye that could affect vision or safety assessments
- Have monocular vision (fellow eye Snellen BCVA is 20/200 or worse
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Ocular Therapeutix
Altamonte Springs, Florida, 32701
Ocular Therapeutix
Bakersfield, California, 93309
Ocular Therapeutix
Oxnard, California, 93036
Ocular Therapeutix
Reno, Nevada, 89502
Ocular Therapeutix
St. Petersburg, Florida, 33711
Ocular Therapeutix
The Woodlands, Texas, 77384
About this study
Official title: A Prospective Multicenter, Double-Masked, Randomized, Parallel-Group, Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI (Axitinib Implant) for Intravitreal Use in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)
Evaluate the safety, tolerability, and efficacy of OTX-TKI for intravitreal use in subjects with Neovascular Age-Related Macular Degeneration
Read the detailed description
Multicenter, double masked, randomized, parallel-group study to evaluate the safety, tolerability, and efficacy of OTX-TKI for intravitreal use in subjects with Neovascular Age-Related Macular Degeneration
- Being tested
- OTX-TKI/Sham, Aflibercept/Sham
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTX-TKI/ShamDrug
OTX-TKI is one dose so subsequent visits will be sham to maintain the mask
Aflibercept/ShamDrug
Also called Eylea
Aflibercept administered every 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| OTX-TKI | Active comparator | Not described Receives: Drug: OTX-TKI/Sham |
| Aflibercept | Active comparator | Not described Receives: Drug: Aflibercept/Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Incidence and severity of treatment emergent adverse events
Measured: Through study completion, an average of 1 year
Secondary outcomes (5)
BCVA changes
BCVA Changes from Baseline
Measured: Through study completion, an average of 1 year
Central subfield thickness changes
Central subfield thickness changes from baseline
Measured: Through study completion, an average of 1 year
Rescue Therapy
Proportion of subjects receiving rescue therapy
Measured: Through study completion, an average of 1 year
Absence of Fluid
Proportion of subjects with absence of foveal fluid
Measured: Through study completion, an average of 1 year
Number of injections
Number of injections from baseline
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start28 Jul 2021
- Primary completion6 Feb 2023
- Study completion18 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-Related Macular DegenerationStudies 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
- 3:1
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ocular Therapeutix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989699
- Sponsor's protocol ID
- OTX-TKI-2020-101
- Status last verified
- Jan 2024
- First submitted
- 2 Jul 2021
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter, Double-Masked, Randomized, Parallel-Group, Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI (Axitinib Implant) for Intravitreal Use in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)
- ClinicalTrials.gov ID
- NCT04989699
- Acronym / sponsor ID
- OTX-TKI-2020-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Ocular Therapeutix, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 6 Feb 2023 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 4 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.
Evaluate the safety, tolerability, and efficacy of OTX-TKI for intravitreal use in subjects with Neovascular Age-Related Macular Degeneration
Detailed description
Multicenter, double masked, randomized, parallel-group study to evaluate the safety, tolerability, and efficacy of OTX-TKI for intravitreal use in subjects with Neovascular Age-Related Macular Degeneration
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 3:1
| Arm | Type | Receives |
|---|---|---|
| OTX-TKI | Active comparator | Drug: OTX-TKI/Sham |
| Aflibercept | Active comparator | Drug: Aflibercept/Sham |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have a diagnosis, within 3 years of screening, of previously treated subfoveal neovascularization (SFNV) secondary to nAMD with leakage involving the fovea, previously treated with documented evidence of an initially favorable clinical response to anti-VEGF therapy (i.e. aflibercept, ranibizumab, brolucizumab, or bevacizumab).
- The macular appearance on OCT is considered to be free of excess intraretinal and/or subretinal fluid as judged by the investigator.
- Must have received at least 3 anti-VEGF injections in the past year.
- Have received the most recent anti-VEGF injection within the past 1-4 weeks prior to screening visit.
- BCVA ETDRS score between 24 and 83 letters (~20/25 to ~20/320 Snellen equivalent)
Key exclusion criteria (3 listed)
- Have evidence of a scar, fibrosis or atrophy of >50% of the total lesion in the study eye
- Have presence of a disease other than choroidal neovascular membrane (CNVM) due to AMD in the study eye that could affect vision or safety assessments
- Have monocular vision (fellow eye Snellen BCVA is 20/200 or worse
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-TKI/ShamOTX-TKI is one dose so subsequent visits will be sham to maintain the mask | Drug | OTX-TKI |
| Aflibercept/ShamAlso: EyleaAflibercept administered every 8 weeks | Drug | Aflibercept |
Primary outcome
Safety and Tolerability
Time frame: Through study completion, an average of 1 year
Incidence and severity of treatment emergent adverse events
5 secondary outcomes
BCVA changes
Time frame: Through study completion, an average of 1 year
Central subfield thickness changes
Time frame: Through study completion, an average of 1 year
Rescue Therapy
Time frame: Through study completion, an average of 1 year
Absence of Fluid
Time frame: Through study completion, an average of 1 year
Number of injections
Time frame: Through study completion, an average of 1 year
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 26 Jan 2024.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Neovascular Age-Related Macular Degeneration, run by Ocular Therapeutix, Inc. at 6 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 5 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: finished, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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. 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?
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?
Safety and Tolerability (time frame: Through study completion, an average of 1 year). 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 26 Jan 2024.