Clinical trial NCT03835884: A Study Assessing AR-13503 Implant in Subjects With nAMD or DME
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neovascular Age-related Macular Degeneration
Diabetic Macular Edema
Keywords: Neovascular AMD
Diabetic macular edema
Diabetic retinopathy
Vascular endothelial growth factor
Intravitreal injection
Lead sponsor: Aerie Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2019-02-11
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of ocular and non-ocular TEAEs
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Retinal Research Institute, LLC
state: Arizona
city: Beverly Hills
country: United States
facility: Retina-Vitreous Associates Medical Group
state: California
city: Walnut Creek
country: United States
facility: Bay Area Retina Associates
state: California
city: Eugene
country: United States
facility: Sterling Vision, PC dba Oregon Retina
state: Oregon
city: Harlingen
country: United States
facility: Valley Retina Institute, P.A.
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthamology Associates
state: Texas
Study officials:
affiliation: Aerie Pharmaceuticals, Inc.
name: Kevin Kerr
role: STUDY_DIRECTOR
References: