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

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ClinicalTrials.gov Identifier: NCT03739593
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Macular Edema Drug: AR-1105-CF1 Drug: AR-1105-CF2 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label, Safety and Proof-of-concept Study to Assess Safety, Tolerability and Efficacy of AR-1105 in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO)
Actual Study Start Date : March 13, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: 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
Drug: AR-1105-CF1
AR-1105 clinical formulation 1 (AR-1105-CF1)
Other Name: AR-1105-CF1 (dexamethasone intravitreal implant)

Experimental: 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
Drug: AR-1105-CF2
AR-1105 clinical formulation 2 (AR-1105-CF2)
Other Name: AR-1105-CF2 (dexamethasone intravitreal implant)




Primary Outcome Measures :
  1. Safety Tolerability: Number of ocular and non-ocular TEAEs [ Time Frame: Up to 6 months treatment duration ]
    Number of ocular and non-ocular treatment-emergent adverse events (TEAEs), summarized at the subject level by system organ class and preferred term, and also by severity and relatedness to treatment. Ocular TEAEs will be summarized separately for study and fellow eyes.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03739593


Contacts
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Contact: Nancy Ramirez, MS 888-594-5111 nramirez@aeriepharma.com
Contact: Jae Lopez 888-594-5111 jlopez@aeriepharma.com

Locations
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United States, Arizona
Retinal Research Institute, LLC Recruiting
Phoenix, Arizona, United States, 85053
United States, California
Retina Vitreous Associates Recruiting
Beverly Hills, California, United States, 90211
Doheny Eye Center, UCLA Not yet recruiting
Los Angeles, California, United States, 91105
Byers Eye Institute at Stanford Recruiting
Palo Alto, California, United States, 94303
California Retina Consultants Recruiting
Santa Barbara, California, United States, 93103
California Retina Consultants Recruiting
Santa Maria, California, United States, 93454
United States, Florida
Florida Eye Clinic Recruiting
Altamonte Springs, Florida, United States, 32701
Center for Retina & Macular Disease Recruiting
Lakeland, Florida, United States, 33805
Retina Specialty Institute Recruiting
Pensacola, Florida, United States, 32503
United States, Indiana
Midwest Eye Institute Withdrawn
Indianapolis, Indiana, United States, 46290
United States, Massachusetts
Ophthalmic Consultants of Boston Not yet recruiting
Boston, Massachusetts, United States, 02114
United States, Michigan
Specialty Eye Institute Recruiting
Jackson, Michigan, United States, 49202
United States, New Jersey
Mid-Atlantic Retina Not yet recruiting
Cherry Hill, New Jersey, United States, 08034
United States, Ohio
Cleveland Eye Clinic Not yet recruiting
Brecksville, Ohio, United States, 44141
United States, Texas
Retina Research Institute of Texas Recruiting
Abilene, Texas, United States, 79606
Texas Retina Associates Recruiting
Arlington, Texas, United States, 76012
Valley Retina Institute, PA Recruiting
McAllen, Texas, United States, 78503
Medical Center Ophthalmology Associates Recruiting
San Antonio, Texas, United States, 78240
Retina Consultants of Houston Recruiting
The Woodlands, Texas, United States, 77384
Sponsors and Collaborators
Aerie Pharmaceuticals
Investigators
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Study Director: Theresa Heah, MD, MBA Aerie Pharmaceuticals, Inc.

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Responsible Party: Aerie Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03739593     History of Changes
Other Study ID Numbers: AR-1105-CS201
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aerie Pharmaceuticals:
Macular Edema
Retinal Vein Occlusion
Dexamethasone Intravitreal Implant

Additional relevant MeSH terms:
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Edema
Macular Edema
Retinal Vein Occlusion
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action