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

NCT ID: NCT03739593

Last Updated: 2022-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-13
• Study Completion Date: 2020-07-09

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.

Detailed Description

AR-1105 is a dexamethasone containing implant drug delivery system that is injected into the back of the eye. It is designed to dissolve slowly over time, continuously releasing a consistent low dose of steroid to treat the symptoms of RVO and associated inflammation with a goal of halting further visual disturbance and damage, and also possibly restoring some vision as symptoms are controlled. In this study, 2 different formulations are being tested to find the optimum combination of efficacy, safety and durability that will offer patients a potential treatment option that is as safe and effective as the treatments currently available, but which requires less frequent injections and potentially has a lower risk for certain side-effects.

Conditions

Macular Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AR-1105-CF1

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

Group Type: EXPERIMENTAL

AR-1105-CF1

Intervention Type: DRUG

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

AR-1105-CF2

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

Group Type: EXPERIMENTAL

AR-1105-CF2

Intervention Type: DRUG

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

Interventions

AR-1105-CF1

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

Intervention Type: DRUG

AR-1105-CF2

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

Intervention Type: DRUG

Other Intervention Names

AR-1105-CF1 (dexamethasone intravitreal implant); AR-1105-CF2 (dexamethasone intravitreal implant)

Eligibility Criteria

Inclusion Criteria

1. At least 18 years of age

2. 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

3. 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

4. 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

5. 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

6. Be able to understand and willing to provide written informed consent.

7. Be willing and able to adhere to the instructions set forth in the study protocol

Exclusion Criteria

Ophthalmic:

1. Presence of a clinically significant epiretinal membrane, active retinal or optic disc neovascularization, active or history of choroidal neovascularization, presence of rubeosis iridis

2. History or presence of herpetic infection, toxoplasmosis, chorioretinopathy.

3. Subjects with moderate non-proliferative diabetic retinopathy or worse in either eye are excluded from participation

4. Any active infection

5. Aphakia, significant posterior capsule tear or iris trauma in the study eye

6. Anterior-chamber intraocular lens

7. Clinically significant media opacity

8. History of glaucoma or visual field loss

9. Ocular hypertension in the study eye at qualification, (with or without treatment)

10. History of corticosteroid-induced IOP increase in either eye

11. Ocular condition in the study eye that, in the opinion of the investigator, would prevent a 15-letter improvement in visual acuity

12. Received an intraocular steroid injection or implant within 6 months or any anti-VEGF treatment within 2 months prior to screening. Prior treatment with RETISERT® or ILUVIEN® or pan-retinal photocoagulation (PRP) is exclusionary

13. 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

14. Currently using topical corticosteroids in the vicinity of the eyes within the 1 month prior to Visit 1

15. Periocular depot of steroids placed within 6 months prior to qualification

16. Ocular medications that are specifically disallowed in this protocol for any condition during the study or within the specified timeframe prior to Visit 2

17. Have progressive optic nerve disease or retinal disease other than retinopathy due to RVO that affects BCVA

Systemic:

18. Currently using or anticipating the use of systemic corticosteroids during the study (with the exception of inhaled, intranasal or topical corticosteroids)

19. Any clinically significant or uncontrolled serious or severe medical or psychiatric condition

20. Participation in any other interventional clinical study within 30 days prior to Visit 1

21. History of hypersensitivity or poor tolerance to any components of the preparations to be used in this study such as dexamethasone or biodegradable polymer (PLGA) excipients or fluorescein

22. Systemic condition that may confound the study outcome per the investigator's opinion

23. Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aerie Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Rowan

Role: STUDY_DIRECTOR

Aerie Pharmaceuticals, Inc.

Locations

Retinal Research Institute, LLC

Phoenix, Arizona, United States

Retina Vitreous Associates

Beverly Hills, California, United States

Byers Eye Institute at Stanford

Palo Alto, California, United States

Florida Eye Clinic

Altamonte Springs, Florida, United States

Center for Retina & Macular Disease

Lakeland, Florida, United States

Retina Specialty Institute

Pensacola, Florida, United States

Mid-Atlantic Retina

Cherry Hill, New Jersey, United States

Cleveland Clinic- Cole Eye Institute

Cleveland, Ohio, United States

Retina Research Institute of Texas

Abilene, Texas, United States

Texas Retina Associates

Arlington, Texas, United States

Medical Center Ophthalmology Associates

San Antonio, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36542081 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

AR-1105-CS201

Identifier Type: -

Identifier Source: org_study_id