Neovascular Age-related Macular DegenerationPhase 1NCT03630315
CLN-0046: Treatment of AMD Subjects With OTX-TKI
A Phase 1 study testing OTX-TKI and Anti-VEGF in people with Neovascular Age-related Macular Degeneration, run by Ocular Therapeutix, Inc. at 6 sites in Australia.
Trial summary
To evaluate the safety, tolerability and efficacy of OTX-TKI for intravitreal use, in subjects who have neovascular age-related macular degeneration (AMD). Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Neovascular Age-related Macular Degeneration
- What is being tested?
- OTX-TKI and Anti-VEGF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 6 sitesAustralia
- Study dates
- 18 Feb 2019to 10 Jan 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 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are at least 50 years of age
- Are eligible for standard therapy
- Have active primary CNVM secondary to AMD, either newly diagnosed or previously treated with documented response to anti-VEGF therapy in the study eye [primary subfoveal CNV secondary to AMD including juxtafoveal lesions that affect the fovea] documented by FA and SD-OCT
- Are female who is postmenopausal for at least 12 months prior to screening or surgically sterile; or male or female of childbearing potential willing to use two forms of adequate contraception
- Are able and willing to comply with all study requirements and visits
Who cannot join
- Have previous laser photocoagulation to the center of the fovea in the study eye
- Have participated in any study involving an investigational drug either in the U.S. or outside the U.S. within the past 30 days
- Are an employee of the site that is directly involved in the management, administration, or support of the study, or be an immediate family member of the same
- Have a presence of a disease other than CNVM due to AMD in the study eye that could affect vision or safety assessments
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Australia6 sites
Ocular Therapeutix, Inc.
Adelaide
Ocular Therapeutix, Inc.
Albury
Ocular Therapeutix, Inc.
Melbourne
Ocular Therapeutix, Inc.
Sydney, Site 1
Ocular Therapeutiux, Inc.
Sydney, Site 2
Ocular Therapeutiux, Inc.
Sydney, Site 3
About this study
Official title: A Phase 1 Open-Label, Dose Escalation Study of OTX-TKI for Intravitreal Use in Subjects With Neovascular Age-Related Macular Degeneration (AMD)
To evaluate the safety, tolerability and efficacy of OTX-TKI for intravitreal use, in subjects who have neovascular age-related macular degeneration (AMD).
Read the detailed description
A multi-center, dose escalation, Phase 1, safety, tolerability and efficacy study to evaluate three dose groups of the OTX-TKI implant to treat subjects with a diagnosis of primary subfoveal neovascularization secondary to AMD.
- Being tested
- OTX-TKI, Anti-VEGF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTX-TKIDrug
OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).
OTX-TKIDrug
OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).
OTX-TKIDrug
OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).
OTX-TKIDrug
OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).
Anti-VEGFDrug
Also called aflibercept, bevacizumab, ranibizumab
Standard of care therapy used to block vascular endothelial growth factor
OTX-TKIDrug
OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).
Anti-VEGFDrug
Also called aflibercept, bevacizumab, ranibizumab
Standard of care therapy used to block vascular endothelial growth factor
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (Low Dose) | Experimental | Subjects will receive a low dose of OTX-TKI Receives: Drug: OTX-TKI |
| Cohort 2 (Middle Dose) | Experimental | Subjects will receive a middle dose of OTX-TKI. Receives: Drug: OTX-TKI |
| Cohort 3 (High Dose) | Experimental | Subjects will receive a high dose of OTX-TKI. Receives: Drug: OTX-TKI |
| Cohort 3 (Anti-VEGF) | Experimental | Subjects will receive OTX-TKI plus a single anti-VEGF injection Receives: Drug: OTX-TKI; Drug: Anti-VEGF |
| Cohort 4 (High Dose) | Experimental | Subjects will receive a high dose of OTX-TKI. Receives: Drug: OTX-TKI |
| Cohort 4 (Anti-VEGF) | Experimental | Subjects will receive OTX-TKI plus a single anti-VEGF injection Receives: Drug: OTX-TKI; Drug: Anti-VEGF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events for each subject
All adverse events from screening through end of study will be captured
Measured: 9 months
Secondary outcomes (1)
Determine the Maximum Tolerated Dose of the OTX-TKI injection
A Central Reading Center will evaluate multiple imaging modalities to confirm evidence of biological activity for subjects that have been treated with the OTX-TKI injection. If all subjects tolerate lower dosages, additional subjects will be treated at higher dosages. All data will be evaluated by the DSMC who, in concert with the Medical Monitor, will determine the Maximally Tolerated Dose.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start18 Feb 2019
- Primary completion10 Jan 2024
- Study completion10 Jan 2024
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
- Sequential
- Masking
- None (open label)
- Enrolment
- 29 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
- NCT03630315
- Sponsor's protocol ID
- CLN-0046
- Status last verified
- Jul 2024
- First submitted
- 1 Jun 2018
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-Label, Dose Escalation Study of OTX-TKI for Intravitreal Use in Subjects With Neovascular Age-Related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT03630315
- Acronym / sponsor ID
- CLN-0046
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Ocular Therapeutix, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 14 Aug 2018 (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.
To evaluate the safety, tolerability and efficacy of OTX-TKI for intravitreal use, in subjects who have neovascular age-related macular degeneration (AMD).
Detailed description
A multi-center, dose escalation, Phase 1, safety, tolerability and efficacy study to evaluate three dose groups of the OTX-TKI implant to treat subjects with a diagnosis of primary subfoveal neovascularization secondary to AMD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (Low Dose) | Experimental | Drug: OTX-TKISubjects will receive a low dose of OTX-TKI |
| Cohort 2 (Middle Dose) | Experimental | Drug: OTX-TKISubjects will receive a middle dose of OTX-TKI. |
| Cohort 3 (High Dose) | Experimental | Drug: OTX-TKISubjects will receive a high dose of OTX-TKI. |
| Cohort 3 (Anti-VEGF) | Experimental | Drug: OTX-TKI, Drug: Anti-VEGFSubjects will receive OTX-TKI plus a single anti-VEGF injection |
| Cohort 4 (High Dose) | Experimental | Drug: OTX-TKISubjects will receive a high dose of OTX-TKI. |
| Cohort 4 (Anti-VEGF) | Experimental | Drug: OTX-TKI, Drug: Anti-VEGFSubjects will receive OTX-TKI plus a single anti-VEGF injection |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Are at least 50 years of age
- Are eligible for standard therapy
- Have active primary CNVM secondary to AMD, either newly diagnosed or previously treated with documented response to anti-VEGF therapy in the study eye [primary subfoveal CNV secondary to AMD including juxtafoveal lesions that affect the fovea] documented by FA and SD-OCT
- Are female who is postmenopausal for at least 12 months prior to screening or surgically sterile; or male or female of childbearing potential willing to use two forms of adequate contraception
- Are able and willing to comply with all study requirements and visits
Key exclusion criteria (4 listed)
- Have previous laser photocoagulation to the center of the fovea in the study eye
- Have participated in any study involving an investigational drug either in the U.S. or outside the U.S. within the past 30 days
- Are an employee of the site that is directly involved in the management, administration, or support of the study, or be an immediate family member of the same
- Have a presence of a disease other than CNVM due to AMD in the study eye that could affect vision or safety assessments
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-TKIOTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI). | Drug | Cohort 1 (Low Dose) |
| OTX-TKIOTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI). | Drug | Cohort 2 (Middle Dose) |
| OTX-TKIOTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI). | Drug | Cohort 3 (High Dose) |
| OTX-TKIOTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI). | Drug | Cohort 3 (Anti-VEGF) |
| Anti-VEGFAlso: aflibercept, bevacizumab, ranibizumabStandard of care therapy used to block vascular endothelial growth factor | Drug | Cohort 3 (Anti-VEGF) |
| OTX-TKIOTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI). | Drug | Cohort 4 (Anti-VEGF), Cohort 4 (High Dose) |
| Anti-VEGFAlso: aflibercept, bevacizumab, ranibizumabStandard of care therapy used to block vascular endothelial growth factor | Drug | Cohort 4 (Anti-VEGF) |
Primary outcome
Incidence of treatment emergent adverse events for each subject
Time frame: 9 months
All adverse events from screening through end of study will be captured
1 secondary outcome
Determine the Maximum Tolerated Dose of the OTX-TKI injection
Time frame: 9 months
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 10 Jul 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 testing OTX-TKI and Anti-VEGF in people with Neovascular Age-related Macular Degeneration, run by Ocular Therapeutix, Inc. at 6 sites 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 5 inclusion and 4 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 10 Jul 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 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 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?
Incidence of treatment emergent adverse events for each subject (time frame: 9 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 10 Jul 2024.