Macular EdemaPhase 2NCT03739593
Study Assessing AR-1105 in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO)
A Phase 2 study testing AR-1105-CF1 and AR-1105-CF2 in people with Macular Edema, run by Aerie Pharmaceuticals at 11 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Macular Edema
- What is being tested?
- AR-1105-CF1 and AR-1105-CF2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 11 sitesUnited States
- Study dates
- 13 Mar 2019to 9 Jul 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 25Show fewer
- 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
- 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
- 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
- Ocular medications that are specifically disallowed in this protocol for any condition during the study or within the specified timeframe prior to Visit 2
- Have progressive optic nerve disease or retinal disease other than retinopathy due to RVO that affects BCVA
- Systemic:
- Currently using or anticipating the use of systemic corticosteroids during the study (with the exception of inhaled, intranasal or topical corticosteroids)
- Any clinically significant or uncontrolled serious or severe medical or psychiatric condition
- Participation in any other interventional clinical study within 30 days prior to Visit 1
- 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
- Systemic condition that may confound the study outcome per the investigator's opinion
- Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Retina Research Institute of Texas
Abilene, Texas, 79606
Florida Eye Clinic
Altamonte Springs, Florida, 32701
Texas Retina Associates
Arlington, Texas, 76012
Retina Vitreous Associates
Beverly Hills, California, 90211
Mid-Atlantic Retina
Cherry Hill, New Jersey, 08034
Cleveland Clinic- Cole Eye Institute
Cleveland, Ohio, 44195
Center for Retina & Macular Disease
Lakeland, Florida, 33805
Byers Eye Institute at Stanford
Palo Alto, California, 94303
Retina Specialty Institute
Pensacola, Florida, 32503
Retinal Research Institute, LLC
Phoenix, Arizona, 85053
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240
About this study
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)
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.
Read the 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
- Being tested
- AR-1105-CF1, AR-1105-CF2
- Keywords
- Macular Edema, Retinal Vein Occlusion, Dexamethasone Intravitreal Implant
- Medical subject headings
- Macular Edema, Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR-1105-CF1Drug
Also called AR-1105-CF1 (dexamethasone intravitreal implant)
AR-1105 clinical formulation 1 (AR-1105-CF1)
AR-1105-CF2Drug
Also called AR-1105-CF2 (dexamethasone intravitreal implant)
AR-1105 clinical formulation 2 (AR-1105-CF2)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: AR-1105-CF2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 6 months treatment duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start13 Mar 2019
- Primary completion14 May 2020
- Study completion9 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aerie Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susan Rowan, Study director, Aerie Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03739593
- Sponsor's protocol ID
- AR-1105-CS201
- Status last verified
- Feb 2022
- First submitted
- 8 Nov 2018
- Last updated
- 28 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36542081
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03739593
- Acronym / sponsor ID
- AR-1105-CS201
- Conditions
- Macular Edema
- Keywords
- Macular Edema, Retinal Vein Occlusion, Dexamethasone Intravitreal Implant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Aerie PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- 14 May 2020 (actual)
- Study completion
- 9 Jul 2020 (actual)
- First posted
- 14 Nov 2018 (actual)
- Results
- Posted 2 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| AR-1105-CF1 | Experimental | Drug: AR-1105-CF1Single 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 |
| AR-1105-CF2 | Experimental | Drug: AR-1105-CF2Single 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AR-1105-CF1Also: AR-1105-CF1 (dexamethasone intravitreal implant)AR-1105 clinical formulation 1 (AR-1105-CF1) | Drug | AR-1105-CF1 |
| AR-1105-CF2Also: AR-1105-CF2 (dexamethasone intravitreal implant)AR-1105 clinical formulation 2 (AR-1105-CF2) | Drug | AR-1105-CF2 |
Primary outcome
Safety Tolerability: Number of Ocular and Non-ocular TEAEs
Time frame: Up to 6 months treatment duration
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36542081Singer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Rowan study director
Aerie Pharmaceuticals, Inc.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AR-1105-CF1 and AR-1105-CF2 in people with Macular Edema, run by Aerie Pharmaceuticals at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Tolerability: Number of Ocular and Non-ocular TEAEs (time frame: Up to 6 months treatment duration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03739593, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2022.