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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03630315




Registration number
NCT03630315
Ethics application status
Date submitted
1/06/2018
Date registered
14/08/2018
Date last updated
10/07/2024

Titles & IDs
Public title
CLN-0046: Treatment of AMD Subjects With OTX-TKI
Scientific title
A Phase 1 Open-Label, Dose Escalation Study of OTX-TKI for Intravitreal Use in Subjects With Neovascular Age-Related Macular Degeneration (AMD)
Secondary ID [1] 0 0
CLN-0046
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neovascular Age-related Macular Degeneration 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 - OTX-TKI
Treatment: Drugs - OTX-TKI
Treatment: Drugs - OTX-TKI
Treatment: Drugs - OTX-TKI
Treatment: Drugs - Anti-VEGF
Treatment: Drugs - OTX-TKI
Treatment: Drugs - Anti-VEGF

Experimental: Cohort 1 (Low Dose) - Subjects will receive a low dose of OTX-TKI

Experimental: Cohort 2 (Middle Dose) - Subjects will receive a middle dose of OTX-TKI.

Experimental: Cohort 3 (High Dose) - Subjects will receive a high dose of OTX-TKI.

Experimental: Cohort 3 (Anti-VEGF) - Subjects will receive OTX-TKI plus a single anti-VEGF injection

Experimental: Cohort 4 (High Dose) - Subjects will receive a high dose of OTX-TKI.

Experimental: Cohort 4 (Anti-VEGF) - Subjects will receive OTX-TKI plus a single anti-VEGF injection


Treatment: Drugs: OTX-TKI
OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).

Treatment: Drugs: OTX-TKI
OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).

Treatment: Drugs: OTX-TKI
OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).

Treatment: Drugs: OTX-TKI
OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).

Treatment: Drugs: Anti-VEGF
Standard of care therapy used to block vascular endothelial growth factor

Treatment: Drugs: OTX-TKI
OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).

Treatment: Drugs: Anti-VEGF
Standard of care therapy used to block vascular endothelial growth factor
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of treatment emergent adverse events for each subject
Timepoint [1] 0 0
9 months
Secondary outcome [1] 0 0
Determine the Maximum Tolerated Dose of the OTX-TKI injection
Timepoint [1] 0 0
9 months

Eligibility
Key inclusion criteria
* 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
Minimum age
50 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/02/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/01/2024
Sample size
Target
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
Site 1Site 2Site
Recruitment hospital [1] 0 0
Ocular Therapeutix, Inc. - Sydney
Recruitment hospital [2] 0 0
Ocular Therapeutiux, Inc. - Sydney
Recruitment hospital [3] 0 0
Ocular Therapeutix, Inc. - Adelaide
Recruitment hospital [4] 0 0
Ocular Therapeutix, Inc. - Albury
Recruitment hospital [5] 0 0
Ocular Therapeutix, Inc. - Melbourne
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Adelaide
Recruitment postcode(s) [3] 0 0
- Albury
Recruitment postcode(s) [4] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ocular Therapeutix, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To evaluate the safety, tolerability and efficacy of OTX-TKI for intravitreal use, in subjects who have neovascular age-related macular degeneration (AMD).
Trial website
https://clinicaltrials.gov/study/NCT03630315
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03630315