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

Diabetic Macular Edema Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03835884
• Other study ID #: AR-13503-CS201
• Status: Completed
• Phase: Phase 1
• Start date: June 24, 2019
• Est. completion date: May 12, 2022

Study information

• Verified date: February 2023
• Source: Aerie Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 12, 2022
• Est. primary completion date: May 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Degeneration
• Macular Edema
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

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
• AR-13503 Implant 21.2 Dose
AR-13503 Implant 21.2 Dose (21.2 µg) administered as intravitreal implants into a single eye
• AR-13503 42.4 Dose
AR-13503 Implant 42.4 Dose (42.4 µg) administered as intravitreal implants into a single eye
• AR-13503 63.6 Dose
AR-13503 Implant 63.6 Dose (63.6 µg) administered as intravitreal implants into a single eye

Locations

Country	Name	City	State
United States	Retina-Vitreous Associates Medical Group	Beverly Hills	California
United States	Sterling Vision, PC dba Oregon Retina	Eugene	Oregon
United States	Retinal Research Institute, LLC	Gilbert	Arizona
United States	Valley Retina Institute, P.A.	Harlingen	Texas
United States	Medical Center Ophthamology Associates	San Antonio	Texas
United States	Bay Area Retina Associates	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Aerie Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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