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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

Study of AR-14034 in Participants With Neovascular Age-Related Macular Degeneration (nAMD)

A Phase 1/2 Two-Stage Dose Escalation and Randomized Parallel-Group Study to Evaluate the Safety, Preliminary Treatment Effects, and Durability of AR-14034 Sustained Release Implant Compared to Intravitreal Anti-Vascular Endothelial Growth Factor Treatment in Participants With Neovascular Age-Related Macular Degeneration

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The primary purpose of this study is to evaluate the safety and durability of single- and repeat administration of AR-14034 Sustained Release (SR) in subjects with neovascular age-related macular degeneration (nAMD).

Who May Be Eligible (Plain English)

Key Inclusion Criteria \[Stage 1 and Stage 2\]: - Presence of an active choroidal neovascularization (CNV) lesion secondary to age-related macular degeneration (AMD); - Best corrected visual acuity (BCVA) between 80 and 35 letters (20/25 to 20/200 Snellen equivalent) in the study eye; - BCVA greater than 20 letters (approximately 20/400 Snellen equivalent) in the non-study eye; - Media clarity and pupillary dilation in the study eye sufficient for all planned study procedures; - Capable of giving signed willing to sign a consent form, which includes compliance with the requirements and restrictions listed in the willing to sign a consent form form (ICF) and in this protocol; - Other protocol-specified inclusion criteria may apply. \[Stage 1\]: - Greater than or equal to 3 and less than or equal to 6 prior treatments of an ocular anti-VEGF medication within the 8 months prior to Screening in the study eye, with demonstrated anatomic response, as assessed by the Investigator. \[Stage 2\]: - Treatment-naïve, or diagnosis of exudative neovascular age-related macular degeneration (nAMD) in the study eye. Key Exclusion Criteria \[Stage 1 and Stage 2\]: - History or current ocular disease in the study eye other than nAMD, that, might require medical or surgical intervention during the study; - Structural damage to the macula that is likely to preclude improvement in visual acuity in the study eye after resolution of the nAMD; - Any active intraocular or periocular infection or active intraocular inflammation; - Treatment with ocular anti-VEGF product in the study eye within 28 days before Week 1 \[Stage 1\] or within 56 days before Screening \[Stage 2\]. - Uncontrolled glaucoma in the study eye; - Uncontrolled blood pressure; - Females of child-bearing potential who are pregnant, intending to become pregnant, nursing, or who are not willing to use an acceptable form of contraception for the duration of the study; - Other protocol-specified exclusion criteria may apply. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Key Inclusion Criteria \[Stage 1 and Stage 2\]: * Presence of an active choroidal neovascularization (CNV) lesion secondary to age-related macular degeneration (AMD); * Best corrected visual acuity (BCVA) between 80 and 35 letters (20/25 to 20/200 Snellen equivalent) in the study eye; * BCVA greater than 20 letters (approximately 20/400 Snellen equivalent) in the non-study eye; * Media clarity and pupillary dilation in the study eye sufficient for all planned study procedures; * Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol; * Other protocol-specified inclusion criteria may apply. \[Stage 1\]: * Greater than or equal to 3 and less than or equal to 6 prior treatments of an ocular anti-VEGF medication within the 8 months prior to Screening in the study eye, with demonstrated anatomic response, as assessed by the Investigator. \[Stage 2\]: * Treatment-naïve, or diagnosis of exudative neovascular age-related macular degeneration (nAMD) in the study eye. Key Exclusion Criteria \[Stage 1 and Stage 2\]: * History or current ocular disease in the study eye other than nAMD, that, might require medical or surgical intervention during the study; * Structural damage to the macula that is likely to preclude improvement in visual acuity in the study eye after resolution of the nAMD; * Any active intraocular or periocular infection or active intraocular inflammation; * Treatment with ocular anti-VEGF product in the study eye within 28 days before Week 1 \[Stage 1\] or within 56 days before Screening \[Stage 2\]. * Uncontrolled glaucoma in the study eye; * Uncontrolled blood pressure; * Females of child-bearing potential who are pregnant, intending to become pregnant, nursing, or who are not willing to use an acceptable form of contraception for the duration of the study; * Other protocol-specified exclusion criteria may apply.

Treatments Being Tested

DRUG

AR-14034 SR implant lower dose

AR-14034 SR administered as an intravitreal implant

DRUG

AR-14034 SR implant higher dose

AR-14034 SR administered as an intravitreal implant

DRUG

AR-14034 SR implant

AR-14034 SR administered as an intravitreal implant

DRUG

Aflibercept Injection

Aflibercept administered as a 2 milligram (mg) intravitreal injection

DRUG

Sham procedure

Needleless syringe used to simulate an intravitreal injection

Locations (20)

Trinity Research Group
Dothan, Alabama, United States
Associated Retina Consultants - Gilbert
Gilbert, Arizona, United States
Associated Retina Consultants - Phoenix
Phoenix, Arizona, United States
Retina Associates of SW PC
Tucson, Arizona, United States
The Retina Partners
Encino, California, United States
Retina Associates of Orange County
Laguna Hills, California, United States
Northern California Retina Vitreous Associates Medical Group
Mountain View, California, United States
Eye Research Foundation
Newport Beach, California, United States
Azul Vision Pasadena
Pasadena, California, United States
Retina Consultants of Southern Colorado
Colorado Springs, Colorado, United States
Retina Group of New England | Waterford
Waterford, Connecticut, United States
Florida Retina Institute
Jacksonville, Florida, United States
Mid Florida Eye Center
Mt. Dora, Florida, United States
Florida Retina Institute
Orlando, Florida, United States
Retina Specialty Institute
Pensacola, Florida, United States
Eye Associates of Pinellas
Pinellas Park, Florida, United States
Center for Retina and Macular Disease
Winter Haven, Florida, United States
Southeast Retina Center
Augusta, Georgia, United States
Thomas Eye Group Main Office
Sandy Springs, Georgia, United States
University Retina and Macula Associates, PC
Oak Forest, Illinois, United States