NCT03630315

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2019

Longer than P75 for phase_1

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

February 18, 2019

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2024

Completed
Last Updated

July 10, 2024

Status Verified

July 1, 2024

Enrollment Period

4.9 years

First QC Date

June 1, 2018

Last Update Submit

July 9, 2024

Conditions

Neovascular Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • Incidence of treatment emergent adverse events for each subject

    All adverse events from screening through end of study will be captured

    9 months

Secondary Outcomes (1)

  • Determine the Maximum Tolerated Dose of the OTX-TKI injection

    9 months

Study Arms (6)

Cohort 1 (Low Dose)

EXPERIMENTAL

Subjects will receive a low dose of OTX-TKI

Drug: OTX-TKI

Cohort 2 (Middle Dose)

EXPERIMENTAL

Subjects will receive a middle dose of OTX-TKI.

Drug: OTX-TKI

Cohort 3 (High Dose)

EXPERIMENTAL

Subjects will receive a high dose of OTX-TKI.

Drug: OTX-TKI

Cohort 3 (Anti-VEGF)

EXPERIMENTAL

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

Drug: OTX-TKIDrug: Anti-VEGF

Cohort 4 (High Dose)

EXPERIMENTAL

Subjects will receive a high dose of OTX-TKI.

Drug: OTX-TKI

Cohort 4 (Anti-VEGF)

EXPERIMENTAL

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

Drug: OTX-TKIDrug: Anti-VEGF

Interventions

OTX-TKIDRUG

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

Cohort 1 (Low Dose)
Anti-VEGFDRUG

Standard of care therapy used to block vascular endothelial growth factor

Also known as: aflibercept, bevacizumab, ranibizumab
Cohort 3 (Anti-VEGF)

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Ocular Therapeutix, Inc.

Sydney, Site 1, Australia

Location

Ocular Therapeutiux, Inc.

Sydney, Site 2, Australia

Location

Ocular Therapeutiux, Inc.

Sydney, Site 3, Australia

Location

Ocular Therapeutix, Inc.

Adelaide, Australia

Location

Ocular Therapeutix, Inc.

Albury, Australia

Location

Ocular Therapeutix, Inc.

Melbourne, Australia

Location

MeSH Terms

Interventions

afliberceptBevacizumabRanibizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2018

First Posted

August 14, 2018

Study Start

February 18, 2019

Primary Completion

January 10, 2024

Study Completion

January 10, 2024

Last Updated

July 10, 2024

Record last verified: 2024-07

Locations

AU(6)