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

NCT03835884 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-02-09

No results posted yet for this study

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)

Conditions

Interventions

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

Sponsors & Collaborators

  • Aerie Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Kevin Kerr · Aerie Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-24
Primary Completion
2022-05-12
Completion
2022-05-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03835884 on ClinicalTrials.gov