Study Assessing AR-1105 in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO)

NCT03739593 | Completed Phase 2 Results FDA Drug

• 1 other identifier: AR-1105-CS201
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 11

Brief Summary

This study will evaluate the safety, tolerability and efficacy of AR-1105 (dexamethasone implant) for the treatment of macular edema (ME) due to retinal vein occlusion (RVO). A more durable intravitreal implant containing a low dose of dexamethasone may result in less frequent retreatments, and potentially lower the incidence of steroid-related side effects without compromising efficacy.

Conditions

Macular Edema

Keywords

Macular Edema; Retinal Vein Occlusion; Dexamethasone Intravitreal Implant

Outcome Measures

Primary Outcomes (1)

• Safety Tolerability: Number of Ocular and Non-ocular TEAEs

  Treatment-emergent adverse events summarized at the subject level by system organ class and preferred term are available in the Adverse Events module. Data reported in the table below corresponds to the total number of participants with ocular and non-ocular treatment-emergent adverse events (TEAEs).

  Up to 6 months treatment duration

Study Arms (2)

AR-1105-CF1

EXPERIMENTAL

Single dose of AR-1105-CF1 (dexamethasone, targeted dose of 340 mcg) administered as an intravitreal implant into a single eye of up to 20 subjects who will be followed for 6 months

Drug: AR-1105-CF1

AR-1105-CF2

EXPERIMENTAL

Single dose of AR-1105-CF2 (dexamethasone, targeted dose of 340 mcg) administered as an intravitreal implant into a single eye of up to 20 subjects who will be followed for 6 months

Drug: AR-1105-CF2

Interventions

AR-1105-CF1 DRUG

AR-1105 clinical formulation 1 (AR-1105-CF1)

Also known as: AR-1105-CF1 (dexamethasone intravitreal implant)

AR-1105-CF1

AR-1105-CF2 DRUG

AR-1105 clinical formulation 2 (AR-1105-CF2)

Also known as: AR-1105-CF2 (dexamethasone intravitreal implant)

AR-1105-CF2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Vision loss due to clinically detectable macular edema (ME) associated with either central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO). Subjects may be treatment-naïve, or if previously-treated with a steroid, must have demonstrated response to treatment
• Duration of macular edema (ME) ≥9 months in subjects with CRVO and ≥12 months in subjects with BRVO. If both eyes are eligible, the study eye will be the eye with worse VA
• Best-corrected visual acuity (BCVA) as measured by the early treatment of diabetic retinopathy study (ETDRS) methodology of between 25 and 70 letters, in the study eye and better than 35 letters, in the non-study eye
• Retinal thickness in the central subfield of \>290 µm (females) and \>305 μm (males) if using a Cirrus (Zeiss) instrument, or if a Spectralis (Heidelberg) instrument is used, thickness should be \>305 μm (females) or \>320 μm (males) in the study eye
• Be able to understand and willing to provide written informed consent.
• Be willing and able to adhere to the instructions set forth in the study protocol

You may not qualify if:

• Ophthalmic:
• Presence of a clinically significant epiretinal membrane, active retinal or optic disc neovascularization, active or history of choroidal neovascularization, presence of rubeosis iridis
• History or presence of herpetic infection, toxoplasmosis, chorioretinopathy.
• Subjects with moderate non-proliferative diabetic retinopathy or worse in either eye are excluded from participation
• Any active infection
• Aphakia, significant posterior capsule tear or iris trauma in the study eye
• Anterior-chamber intraocular lens
• Clinically significant media opacity
• History of glaucoma or visual field loss
• Ocular hypertension in the study eye at qualification, (with or without treatment)
• History of corticosteroid-induced IOP increase in either eye
• Ocular condition in the study eye that, in the opinion of the investigator, would prevent a 15-letter improvement in visual acuity
• Intraocular surgery (including laser refractive or eyelid surgery) within 3 months prior to Visit 1 or anticipated need for ocular surgery or ophthalmic laser treatment during the study treatment period
• Currently using topical corticosteroids in the vicinity of the eyes within the 1 month prior to Visit 1
• Periocular depot of steroids placed within 6 months prior to qualification

Sponsors & Collaborators

• Aerie Pharmaceuticals: lead

Study Sites (11)

Retinal Research Institute, LLC

Phoenix, Arizona, 85053, United States

Location

Retina Vitreous Associates

Beverly Hills, California, 90211, United States

Location

Byers Eye Institute at Stanford

Palo Alto, California, 94303, United States

Location

Florida Eye Clinic

Altamonte Springs, Florida, 32701, United States

Location

Center for Retina & Macular Disease

Lakeland, Florida, 33805, United States

Location

Retina Specialty Institute

Pensacola, Florida, 32503, United States

Location

Mid-Atlantic Retina

Cherry Hill, New Jersey, 08034, United States

Location

Cleveland Clinic- Cole Eye Institute

Cleveland, Ohio, 44195, United States

Location

Retina Research Institute of Texas

Abilene, Texas, 79606, United States

Location

Texas Retina Associates

Arlington, Texas, 76012, United States

Location

Medical Center Ophthalmology Associates

San Antonio, Texas, 78240, United States

Location

Related Publications (1)

• Singer MA, Boyer DS, Williams S, McKee H, Kerr K, Pegoraro T, Trevino L, Kopczynski CC, Hollander DA. PHASE 2 RANDOMIZED STUDY (ORION-1) OF A NOVEL, BIODEGRADABLE DEXAMETHASONE IMPLANT (AR-1105) FOR THE TREATMENT OF MACULAR EDEMA DUE TO CENTRAL OR BRANCH RETINAL VEIN OCCLUSION. Retina. 2023 Jan 1;43(1):25-33. doi: 10.1097/IAE.0000000000003632. Epub 2022 Oct 14.

  PMID: 36542081 DERIVED

MeSH Terms

Conditions

Macular Edema; Retinal Vein Occlusion

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Kevin Kerr, Director of Clinical Development
• Organization: Aerie Pharmaceuticals, Inc

kkerr@aeriepharma.com

(949) 526-8701

Study Officials

• Susan Rowan

  Aerie Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single injection of either of 2 formulations of AR-1105 dexamethasone intravitreal implant (CF1 or CF2) administered in a single eye. An initial safety cohort of up-to 5 subjects may be enrolled onto CF1 prior to the randomized phase. During the randomized phase of the study, subjects will be assigned in a 1:1 ratio to either CF1 or CF2. Each subject will complete a 6-month primary evaluation period. Residual implant assessment will be performed by 3-field fundus photography at Day 7 and at Months 3, 4, 5, and 6, and if necessary at monthly visits thereafter until the subject requires retreatment, or until 1 month after the implant is no longer visible, or to Month 9, whichever comes first.

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 14, 2018
• Study Start: March 13, 2019
• Primary Completion: May 14, 2020
• Study Completion: July 9, 2020
• Last Updated: February 28, 2022
• Results First Posted: July 2, 2021

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)