Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Conditions
Keywords
Neovascular AMD, Diabetic macular edema, Diabetic retinopathy, Vascular endothelial growth factor, Intravitreal injection
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.
Interventions
DRUGAR-13503 Implant 10.6 Dose
AR-13503 Implant 10.6 Dose (10.6 µg) administered as an intravitreal implant into a single eye
DRUGAR-13503 Implant 21.2 Dose
AR-13503 Implant 21.2 Dose (21.2 µg) administered as intravitreal implants into a single eye
DRUGAR-13503 42.4 Dose
AR-13503 Implant 42.4 Dose (42.4 µg) administered as intravitreal implants into a single eye
DRUGAR-13503 63.6 Dose
AR-13503 Implant 63.6 Dose (63.6 µg) administered as intravitreal implants into a single eye
Sponsors
Aerie Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Masking description
No masking
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of ocular and non-ocular TEAEs | 24 weeks | 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. |
Countries
United States
Outcome results
None listed