CLN-0046: Treatment of AMD Subjects With OTX-TKI

Ocular Therapeutix

Status and phase: Completed; Phase 1

Conditions: Neovascular Age-related Macular Degeneration

Treatments: Drug: Anti-VEGF; Drug: OTX-TKI

Study type: Interventional

Funder types: Industry

Identifiers

NCT03630315

CLN-0046

Details and patient eligibility

About

To evaluate the safety, tolerability and efficacy of OTX-TKI for intravitreal use, in subjects who have neovascular age-related macular degeneration (AMD).

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 50 to 100 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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29 participants in 6 patient groups

Cohort 1 (Low Dose)

Experimental group

Description:

Subjects will receive a low dose of OTX-TKI

Treatment:

Drug: OTX-TKI

Drug: OTX-TKI

Drug: OTX-TKI

Drug: OTX-TKI

Drug: OTX-TKI

Cohort 2 (Middle Dose)

Experimental group

Description:

Subjects will receive a middle dose of OTX-TKI.

Treatment:

Drug: OTX-TKI

Drug: OTX-TKI

Drug: OTX-TKI

Drug: OTX-TKI

Drug: OTX-TKI

Cohort 3 (High Dose)

Experimental group

Description:

Subjects will receive a high dose of OTX-TKI.

Treatment:

Drug: OTX-TKI

Drug: OTX-TKI

Drug: OTX-TKI

Drug: OTX-TKI

Drug: OTX-TKI

Cohort 3 (Anti-VEGF)

Experimental group

Description:

Subjects will receive OTX-TKI plus a single anti-VEGF injection

Treatment:

Drug: OTX-TKI

Drug: Anti-VEGF

Drug: OTX-TKI

Drug: OTX-TKI

Drug: Anti-VEGF

Drug: OTX-TKI

Drug: OTX-TKI

Cohort 4 (High Dose)

Experimental group

Description:

Subjects will receive a high dose of OTX-TKI.

Treatment:

Drug: OTX-TKI

Drug: OTX-TKI

Drug: OTX-TKI

Drug: OTX-TKI

Drug: OTX-TKI

Cohort 4 (Anti-VEGF)

Experimental group

Description:

Subjects will receive OTX-TKI plus a single anti-VEGF injection

Treatment:

Drug: OTX-TKI

Drug: Anti-VEGF

Drug: OTX-TKI

Drug: OTX-TKI

Drug: Anti-VEGF

Drug: OTX-TKI

Drug: OTX-TKI