Study to Evaluate Long-Term Safety of Intravitreal OTX-TKI (Axitinib Implant) in Participants With Neovascular Age-Related Macular Degeneration Who Successfully Completed 2-Year OTX-TKI-2023-AMD-301 or OTX-TKI-2023-AMD-303 Study

Purpose

Study to Evaluate Long-Term Safety of Intravitreal OTX-TKI (Axitinib Implant) in Participants with Neovascular Age-Related Macular Degeneration Who Successfully Completed 2-Year OTX-TKI-2023-AMD-301 or OTX-TKI-2023-AMD-303 Study

Condition

  • Neovascular Age-Related Macular Degeneration (nAMD)

Eligibility

Eligible Ages
Over 50 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participants with a diagnosis of nAMD in the study eye who successfully completed Study OTX-TKI-2023-AMD-301 through Week 104 or Study OTX-TKI-2023-AMD-303 through Week 96 - Have adequate ocular media and adequate pupillary dilation in the study eye to permit good quality fundus imaging - Are able and willing to comply with all study requirements and visits - Have provided written informed consent

Exclusion Criteria

  • Have significant intraocular or periocular infection (bacterial, viral, or fungal) in the study eye within 3 months prior to Day 1 - History of intraocular inflammation in the study eye - Have evidence of a rhegmatogenous retinal detachment or visually significant/severe epiretinal membrane, macular hole, tear of the retinal pigment epithelium in the macula, or other macular - Presence of an intercurrent illness or condition that in the opinion of the Investigator, may place the participant at an unacceptable risk, preventing the participant from completing the study or confound the interpretation of study results - Female participants who are pregnant (had a positive urine test at the Baseline visit [Day 1]) or breastfeeding or intend to become pregnant during the study, who are unwilling to use 2 forms of highly effective contraception from baseline until they exit the study or at least 3 months after the last study treatment, whichever is later.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
OTX-TKI
  • Drug: OTX-TKI
    Intravitreal Injection of OTX-TKI

Recruiting Locations

California Retina Consultants (CRC)
Bakersfield, California 93309
Contact:
Luis Lopez
661-524-0162
luis.lopez@californiaretina.com

California Retina Consultants (CRC)
Santa Barbara, California 93103
Contact:
Dilsher Dhoot, MD
781-357-4000
ddhoot@yahoo.com

Retina Group of New England
Waterford, Connecticut 06385
Contact:
Ashley Parent
860-444-1292
aparent@retinagroupofnewengland.com

Retina Group of Florida - Fort Lauderdale
Fort Lauderdale, Florida 33308
Contact:
Eduardo Uchiyama, MD
954-776-6800
euchiyama@rgfla.com

Cumberland Valley Retina Associates
Hagerstown, Maryland 21740
Contact:
Brittany Carson
301-665-1712
BrittanyC@retinacare.net

Mid Atlantic Retina Specialists
Hagerstown, Maryland 21740
Contact:
Adam Gerstenblith, MD
240-313-9500
adamgerstenblith@gmail.com

Palmetto Retina Center
West Columbia, South Carolina 29619
Contact:
Nitin Nigam, MD
803-867-7059
nnigam@palmettoretina.com

Austin Retina Associates
Austin, Texas 78705
Contact:
Robert William Wong, MD
512-451-0103

More Details

Status
Recruiting
Sponsor
Ocular Therapeutix, Inc.

Study Contact

Clinical Project Manager
781-357-4000
clinicalaffairs@ocutx.com