Who is sponsoring NCT03835884?

NCT03835884 is sponsored by Aerie Pharmaceuticals.

What drugs are being tested in NCT03835884?

Interventions in NCT03835884: AR-13503 Implant 10.6 Dose, AR-13503 Implant 21.2 Dose, AR-13503 42.4 Dose, AR-13503 63.6 Dose.

What condition does NCT03835884 study?

NCT03835884 studies Neovascular Age-related Macular Degeneration, Diabetic Macular Edema.

Is NCT03835884 still recruiting?

NCT03835884 is currently completed. Last updated 9 February 2023.

Last reviewed 2023-02-09 · How we verify

NCT03835884

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 9 February 2023

What this trial tests

Phase 1 trial testing AR-13503 Implant 10.6 Dose in Neovascular Age-related Macular Degeneration in 18 participants. Completed in 12 May 2022.

Timeline

24 June 2019

Primary endpoint
12 May 2022

12 May 2022

Quick facts

Lead sponsor	Aerie Pharmaceuticals
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	24 June 2019
Primary completion	12 May 2022
Estimated completion	12 May 2022
Sites	6 locations across United States

Drugs / interventions tested

AR-13503 Implant 10.6 Dose — full drug profile →
AR-13503 Implant 21.2 Dose — full drug profile →
AR-13503 42.4 Dose — full drug profile →
AR-13503 63.6 Dose — full drug profile →

Conditions studied

Neovascular Age-related Macular Degeneration — all drugs for Neovascular Age-related Macular Degeneration →
Diabetic Macular Edema — all drugs for Diabetic Macular Edema →

Sponsor

Aerie Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Neovascular Age-related Macular Degeneration or Diabetic Macular Edema. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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)

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Nanocarriers for ocular drug delivery: current status and translational opportunity.
Gorantla S, Rapalli VK, Waghule T, Singh PP, et al · · 2020 · cited 162× · PMID 35516960 · DOI 10.1039/d0ra04971a
Nanotechnology-based ocular drug delivery systems: recent advances and future prospects.
Li S, Chen L, Fu Y. · · 2023 · cited 113× · PMID 37480102 · DOI 10.1186/s12951-023-01992-2
An update on long-acting therapies in chronic sight-threatening eye diseases of the posterior segment: AMD, DMO, RVO, uveitis and glaucoma.
Ghanchi F, Bourne R, Downes SM, Gale R, et al · · 2022 · cited 35× · PMID 34974541 · DOI 10.1038/s41433-021-01766-w
Recent achievements in nano-based technologies for ocular disease diagnosis and treatment, review and update.
Afarid M, Mahmoodi S, Baghban R. · · 2022 · cited 31× · PMID 35918688 · DOI 10.1186/s12951-022-01567-7
Ocular Drug Delivery: Advancements and Innovations.
Tian B, Bilsbury E, Doherty S, Teebagy S, et al · · 2022 · cited 28× · PMID 36145679 · DOI 10.3390/pharmaceutics14091931
The Application of Rho Kinase Inhibitors in the Management of Glaucoma.
Liu LC, Chen YH, Lu DW. · · 2024 · cited 14× · PMID 38891764 · DOI 10.3390/ijms25115576
Rho-Kinase Inhibitors for the Treatment of Refractory Diabetic Macular Oedema.
Mateos-Olivares M, García-Onrubia L, Valentín-Bravo FJ, González-Sarmiento R, et al · · 2021 · cited 12× · PMID 34359853 · DOI 10.3390/cells10071683
Effects of Rho-Associated Kinase (Rock) Inhibitors (Alternative to Y-27632) on Primary Human Corneal Endothelial Cells.
Peh GSL, Bandeira F, Neo D, Adnan K, et al · · 2023 · cited 9× · PMID 37174707 · DOI 10.3390/cells12091307

Verify or expand the search:

Other recruiting trials for Neovascular Age-related Macular Degeneration

Currently open trials in the same condition.

NCT07275840 — A Study to Evaluate the Efficacy and Safety of IBI302inSubjects With nAMD · Phase 2 · recruiting
NCT06847542 — A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD · Phase 3 · recruiting
NCT07053358 — Safety and Efficacy Evaluation of LX111 Gene Therapy in nAMD Patients · EARLY_PHASE1 · recruiting
NCT06680817 — A Real-World Study to Gain Clinical Insights Into Faricimab (FaReal Study) · recruiting
NCT06495918 — Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- R · Phase 3 · active not recruiting

Other Aerie Pharmaceuticals trials

Trials by the same sponsor.

NCT05493111 — A Long-Term Safety Study Evaluating the Safety and Systemic Exposure of AR-15512 · Phase 3 · completed
NCT05360966 — Study Evaluating the Safety and Efficacy of AR-15512 (COMET-3) · Phase 3 · completed
NCT05285644 — Study Evaluating the Safety and Efficacy of AR-15512 · Phase 3 · completed
NCT05283395 — Rocklatan® Evaluation · Phase 4 · completed
NCT05497479 — Study Evaluating Techniques for Measuring Tear Production · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03835884 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Aerie Pharmaceuticals
Last refreshed: 9 February 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03835884.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing