NCT03835884

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Aerie Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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
DRUG	AR-13503 Implant 21.2 Dose	AR-13503 Implant 21.2 Dose (21.2 µg) administered as intravitreal implants into a single eye
DRUG	AR-13503 42.4 Dose	AR-13503 Implant 42.4 Dose (42.4 µg) administered as intravitreal implants into a single eye
DRUG	AR-13503 63.6 Dose	AR-13503 Implant 63.6 Dose (63.6 µg) administered as intravitreal implants into a single eye

Timeline

• Start date: 2019-06-24
• Primary completion: 2022-05-12
• Completion: 2022-05-12
• First posted: 2019-02-11
• Last updated: 2023-02-09

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study