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

NCT ID: NCT03835884

Last Updated: 2023-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-24
• Study Completion Date: 2022-05-12

Brief Summary

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)

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.

Conditions

Neovascular Age-related Macular Degeneration; Diabetic Macular Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

AR-13503 Implant 10.6 Dose

Intervention Type: DRUG

AR-13503 Implant 10.6 Dose (10.6 µg) administered as an intravitreal implant into a single eye

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

Group Type: EXPERIMENTAL

AR-13503 Implant 21.2 Dose

Intervention Type: DRUG

AR-13503 Implant 21.2 Dose (21.2 µg) administered as intravitreal implants into a single eye

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

Group Type: EXPERIMENTAL

AR-13503 42.4 Dose

Intervention Type: DRUG

AR-13503 Implant 42.4 Dose (42.4 µg) administered as intravitreal implants into a single eye

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.

Group Type: EXPERIMENTAL

AR-13503 63.6 Dose

Intervention Type: DRUG

AR-13503 Implant 63.6 Dose (63.6 µg) administered as intravitreal implants into a single eye

Interventions

AR-13503 Implant 10.6 Dose

AR-13503 Implant 10.6 Dose (10.6 µg) administered as an intravitreal implant into a single eye

Intervention Type: DRUG

AR-13503 Implant 21.2 Dose

AR-13503 Implant 21.2 Dose (21.2 µg) administered as intravitreal implants into a single eye

Intervention Type: DRUG

AR-13503 42.4 Dose

AR-13503 Implant 42.4 Dose (42.4 µg) administered as intravitreal implants into a single eye

Intervention Type: DRUG

AR-13503 63.6 Dose

AR-13503 Implant 63.6 Dose (63.6 µg) administered as intravitreal implants into a single eye

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

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

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aerie Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin Kerr

Role: STUDY_DIRECTOR

Aerie Pharmaceuticals, Inc.

Locations

Retinal Research Institute, LLC

Gilbert, Arizona, United States

Retina-Vitreous Associates Medical Group

Beverly Hills, California, United States

Bay Area Retina Associates

Walnut Creek, California, United States

Sterling Vision, PC dba Oregon Retina

Eugene, Oregon, United States

Valley Retina Institute, P.A.

Harlingen, Texas, United States

Medical Center Ophthamology Associates

San Antonio, Texas, United States

Countries

United States

Other Identifiers

AR-13503-CS201

Identifier Type: -

Identifier Source: org_study_id