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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

Tracking Information
First Submitted Date  ICMJE November 8, 2018
First Posted Date  ICMJE November 14, 2018
Last Update Posted Date May 20, 2019
Actual Study Start Date  ICMJE March 13, 2019
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03739593 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Assessing AR-1105 in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO)
Official Title  ICMJE 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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Macular Edema
Intervention  ICMJE
  • Drug: AR-1105-CF1
    AR-1105 clinical formulation 1 (AR-1105-CF1)
    Other Name: AR-1105-CF1 (dexamethasone intravitreal implant)
  • Drug: AR-1105-CF2
    AR-1105 clinical formulation 2 (AR-1105-CF2)
    Other Name: AR-1105-CF2 (dexamethasone intravitreal implant)
Study Arms  ICMJE
  • 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
    Intervention: Drug: AR-1105-CF1
  • 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
    Intervention: Drug: AR-1105-CF2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 13, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nancy Ramirez, MS 888-594-5111 nramirez@aeriepharma.com
Contact: Jae Lopez 888-594-5111 jlopez@aeriepharma.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03739593
Other Study ID Numbers  ICMJE AR-1105-CS201
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Aerie Pharmaceuticals
Study Sponsor  ICMJE Aerie Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Theresa Heah, MD, MBA Aerie Pharmaceuticals, Inc.
PRS Account Aerie Pharmaceuticals
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP