A Study Assessing AR-13503 Implant in Subjects With nAMD or DME

First-in-Human Study of the Safety of AR-13503 Sustained Release Intravitreal Implant in Subjects With Neovascular Age-Related Macular Degeneration (nAMD) and Subjects With Diabetic Macular Edema (DME)

First-in-Human Study of the Safety of AR-13503 Sustained Release Intravitreal Implant in Subjects with Neovascular Age-Related Macular Degeneration (nAMD) and Subjects with Diabetic Macular Edema (DME)

Study Overview

• Status: Completed
• Conditions: Diabetic Macular Edema; Neovascular Age-related Macular Degeneration
• Intervention / Treatment: Drug: AR-13503 Implant 10.6 Dose; Drug: AR-13503 Implant 21.2 Dose; Drug: AR-13503 42.4 Dose; Drug: AR-13503 63.6 Dose

Detailed Description

This is a first-in-human study conducted in 2 sequential stages; each stage is 24 weeks in duration. Subjects with nAMD and subjects with DME were evaluated in Stage 1. Subjects with DME will be evaluated in Stage 2.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Gilbert, Arizona, United States, 85296
      • Retinal Research Institute, LLC
  • California
    • Beverly Hills, California, United States, 90211
      • Retina-Vitreous Associates Medical Group
    • Walnut Creek, California, United States, 94598
      • Bay Area Retina Associates
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Sterling Vision, PC dba Oregon Retina
  • Texas
    • Harlingen, Texas, United States, 78550
      • Valley Retina Institute, P.A.
    • San Antonio, Texas, United States, 78240
      • Medical Center Ophthamology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria for Subjects with Neovascular Age-Related Macular Degeneration (nAMD)

1. 50 years of age or older
2. Presence of active subfoveal or juxtafoveal Choroidal Neovascularization (CNV) (any subtype) with leakage affecting the fovea secondary to Age-Related Macular Degeneration (AMD)

3. Best Corrected Visual Acuity (BCVA) in the study eye at Baseline (Day 0):

   Stage 1: between 65 and 10 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (20/50 and 20/640 Snellen equivalent)

4. Able and willing to give signed informed consent and follow study instructions

Inclusion Criteria for Subjects with Diabetic Macular Edema (DME)

Subjects with Diabetic Macular Edema (DME) must meet all the following criteria to enter into the study:

1. 18 years of age or older
2. Type 1 or 2 diabetes mellitus with center-involved DME

3. BCVA in the study eye at Baseline (Day 0):

   Stage 1: between 65 and 10 ETDRS letters (20/50 and 20/640 Snellen equivalent) Stage 2: between 70 and 20 ETDRS letters (20/40 and 20/400 Snellen equivalent)

4. Able and willing to give signed informed consent and follow study instructions

Exclusion Criteria for Subjects with Neovascular Age-Related Macular Degeneration (nAMD)

Ophthalmic:

1. Use of intravitreal aflibercept within 8 weeks, ranibizumab or bevacizumab within 6 weeks
2. History of vitreoretinal surgery in the study eye
3. Any ocular disease in the study eye that in the Investigator and Reading Center's opinion may confound assessment of the macula, affect central vision, confound results, or preclude improvement in visual acuity
4. Any current or history of periocular or intraocular inflammation or evidence of infection in either eye
5. Media clarity insufficient to obtain quality fundus and OCT images in the study eye

Systemic:

1. History or current systemic condition that in the Investigator opinion preclude the safe administration of the study treatment or confound results
2. History of allergy or sensitivity to fluorescein or povidone iodine
3. Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control
4. Participation in an investigational study within 30 days of Screening

Exclusion Criteria for Subjects with DME

Ophthalmic:

1. Use of intraocular or periocular corticosteroids within 6 months, aflibercept within 8 weeks, ranibizumab or bevacizumab within 6 weeks
2. History of vitreoretinal surgery in the study eye
3. High risk proliferative diabetic retinopathy in the study eye and related complications
4. Structural damage to the center or the macula that is likely to preclude improvement in visual acuity in the study eye after resolution of the DME
5. Media clarity insufficient to obtain quality fundus and OCT images in the study eye

Systemic:

1. History or current medical condition that in the Investigator's opinion preclude the safe administration of the study treatment or confound results
2. History of allergy or sensitivity to fluorescein or povidone iodine
3. Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control
4. Participation in an investigational study within 30 days of Screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: AR-13503 Implant 10.6 Dose; Single dose of AR-13503 Implant 10.6 Dose (10.6 µg) administered as an intravitreal implant into a single eye of up to 6 subjects (3 nAMD and 3 DME) who will be followed for 24 weeks	Drug: AR-13503 Implant 10.6 Dose; AR-13503 Implant 10.6 Dose (10.6 µg) administered as an intravitreal implant into a single eye
EXPERIMENTAL: AR-13503 Implant 21.2 Dose; Single dose of AR-13503 Implant 21.2 Dose (21.2 µg) administered as intravitreal implants into a single eye of up to 6 subjects (3 nAMD and 3 DME) who will be followed for 24 weeks	Drug: AR-13503 Implant 21.2 Dose; AR-13503 Implant 21.2 Dose (21.2 µg) administered as intravitreal implants into a single eye
EXPERIMENTAL: AR-13503 Implant 42.4 Dose; Single dose of AR-13503 Implant 42.4 Dose (42.4 µg) administered as intravitreal implants into a single eye of up to 6 subjects (3 nAMD and 3 DME) who will be followed for 24 weeks	Drug: AR-13503 42.4 Dose; AR-13503 Implant 42.4 Dose (42.4 µg) administered as intravitreal implants into a single eye
EXPERIMENTAL: AR-13503 Implant 63.6 Dose; Dose of AR-13503 Implant 63.6 Dose (63.6 µg) administered into a single eye of up to 5 subjects (DME) who will be followed for 24 weeks. Subjects may qualify to receive an additional dose at Week 12.	Drug: AR-13503 63.6 Dose; AR-13503 Implant 63.6 Dose (63.6 µg) administered as intravitreal implants into a single eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of ocular and non-ocular TEAEs	Number of ocular and non-ocular treatment-emergent adverse events (TEAEs), summarized at the subject level by system organ class and preferred term, and also by severity and relatedness to treatment.	24 weeks

Collaborators and Investigators

• Sponsor: Aerie Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 24, 2019
• Primary Completion (ACTUAL): May 12, 2022
• Study Completion (ACTUAL): May 12, 2022

Study Registration Dates

• First Submitted: February 7, 2019
• First Submitted That Met QC Criteria: February 7, 2019
• First Posted (ACTUAL): February 11, 2019

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Vascular endothelial growth factor; Neovascular AMD; Diabetic macular edema; Diabetic retinopathy; Intravitreal injection
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema; Wet Macular Degeneration
• Other Study ID Numbers: AR-13503-CS201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No