Neovascular Age-related Macular DegenerationPhase 1NCT03835884
A Study Assessing AR-13503 Implant in Subjects With nAMD or DME
A Phase 1 study testing AR-13503 Implant 10.6 Dose, AR-13503 Implant 21.2 Dose and AR-13503 42.4 Dose in people with Neovascular Age-related Macular Degeneration and Diabetic Macular Edema, run by Aerie Pharmaceuticals at 6 sites in United States.
Trial summary
First-in-Human Study of the Safety of AR-13503 Sustained Release Intravitreal Implant in Subjects with Neovascular Age-Related Macular Degeneration (nAMD) and Subjects with Diabetic Macular Edema (DME) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration, Diabetic Macular Edema
- What is being tested?
- AR-13503 Implant 10.6 Dose, AR-13503 Implant 21.2 Dose and AR-13503 42.4 Dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 6 sitesUnited States
- Study dates
- 24 Jun 2019to 12 May 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Ophthalmic:
- Use of intraocular or periocular corticosteroids within 6 months, aflibercept within 8 weeks, ranibizumab or bevacizumab within 6 weeks
- History of vitreoretinal surgery in the study eye
- High risk proliferative diabetic retinopathy in the study eye and related complications
- Structural damage to the center or the macula that is likely to preclude improvement in visual acuity in the study eye after resolution of the DME
- Media clarity insufficient to obtain quality fundus and OCT images in the study eye
Show all 11Show fewer
- Systemic:
- History or current medical condition that in the Investigator's opinion preclude the safe administration of the study treatment or confound results
- History of allergy or sensitivity to fluorescein or povidone iodine
- Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control
- Participation in an investigational study within 30 days of Screening
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211
Sterling Vision, PC dba Oregon Retina
Eugene, Oregon, 97401
Retinal Research Institute, LLC
Gilbert, Arizona, 85296
Valley Retina Institute, P.A.
Harlingen, Texas, 78550
Medical Center Ophthamology Associates
San Antonio, Texas, 78240
Bay Area Retina Associates
Walnut Creek, California, 94598
About this study
Official title: First-in-Human Study of the Safety of AR-13503 Sustained Release Intravitreal Implant in Subjects With Neovascular Age-Related Macular Degeneration (nAMD) and Subjects With Diabetic Macular Edema (DME)
First-in-Human Study of the Safety of AR-13503 Sustained Release Intravitreal Implant in Subjects with Neovascular Age-Related Macular Degeneration (nAMD) and Subjects with Diabetic Macular Edema (DME)
Read the detailed description
This is a first-in-human study conducted in 2 sequential stages; each stage is 24 weeks in duration. Subjects with nAMD and subjects with DME were evaluated in Stage 1. Subjects with DME will be evaluated in Stage 2.
- Being tested
- AR-13503 Implant 10.6 Dose, AR-13503 Implant 21.2 Dose, AR-13503 42.4 Dose, AR-13503 63.6 Dose
- Keywords
- Neovascular AMD, Diabetic macular edema, Diabetic retinopathy, Vascular endothelial growth factor, Intravitreal injection
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR-13503 Implant 10.6 DoseDrug
AR-13503 Implant 10.6 Dose (10.6 µg) administered as an intravitreal implant into a single eye
AR-13503 Implant 21.2 DoseDrug
AR-13503 Implant 21.2 Dose (21.2 µg) administered as intravitreal implants into a single eye
AR-13503 42.4 DoseDrug
AR-13503 Implant 42.4 Dose (42.4 µg) administered as intravitreal implants into a single eye
AR-13503 63.6 DoseDrug
AR-13503 Implant 63.6 Dose (63.6 µg) administered as intravitreal implants into a single eye
| Study group | Role | What they receive |
|---|---|---|
| AR-13503 Implant 10.6 Dose | Experimental | Single dose of AR-13503 Implant 10.6 Dose (10.6 µg) administered as an intravitreal implant into a single eye of up to 6 subjects (3 nAMD and 3 DME) who will be followed for 24 weeks Receives: Drug: AR-13503 Implant 10.6 Dose |
| AR-13503 Implant 21.2 Dose | Experimental | Single dose of AR-13503 Implant 21.2 Dose (21.2 µg) administered as intravitreal implants into a single eye of up to 6 subjects (3 nAMD and 3 DME) who will be followed for 24 weeks Receives: Drug: AR-13503 Implant 21.2 Dose |
| AR-13503 Implant 42.4 Dose | Experimental | Single dose of AR-13503 Implant 42.4 Dose (42.4 µg) administered as intravitreal implants into a single eye of up to 6 subjects (3 nAMD and 3 DME) who will be followed for 24 weeks Receives: Drug: AR-13503 42.4 Dose |
| AR-13503 Implant 63.6 Dose | Experimental | Dose of AR-13503 Implant 63.6 Dose (63.6 µg) administered into a single eye of up to 5 subjects (DME) who will be followed for 24 weeks. Subjects may qualify to receive an additional dose at Week 12. Receives: Drug: AR-13503 63.6 Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of ocular and non-ocular TEAEs
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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start24 Jun 2019
- Primary completion12 May 2022
- Study completion12 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-related Macular DegenerationStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aerie Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin Kerr, Study director, Aerie Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835884
- Sponsor's protocol ID
- AR-13503-CS201
- Status last verified
- Feb 2023
- First submitted
- 7 Feb 2019
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-Human Study of the Safety of AR-13503 Sustained Release Intravitreal Implant in Subjects With Neovascular Age-Related Macular Degeneration (nAMD) and Subjects With Diabetic Macular Edema (DME)
- ClinicalTrials.gov ID
- NCT03835884
- Acronym / sponsor ID
- AR-13503-CS201
- Keywords
- Neovascular AMD, Diabetic macular edema, Diabetic retinopathy, Vascular endothelial growth factor, Intravitreal injection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Aerie PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 12 May 2022 (actual)
- Study completion
- 12 May 2022 (actual)
- First posted
- 11 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
First-in-Human Study of the Safety of AR-13503 Sustained Release Intravitreal Implant in Subjects with Neovascular Age-Related Macular Degeneration (nAMD) and Subjects with Diabetic Macular Edema (DME)
Detailed description
This is a first-in-human study conducted in 2 sequential stages; each stage is 24 weeks in duration. Subjects with nAMD and subjects with DME were evaluated in Stage 1. Subjects with DME will be evaluated in Stage 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AR-13503 Implant 10.6 Dose | Experimental | Drug: AR-13503 Implant 10.6 DoseSingle dose of AR-13503 Implant 10.6 Dose (10.6 µg) administered as an intravitreal implant into a single eye of up to 6 subjects (3 nAMD and 3 DME) who will be followed for 24 weeks |
| AR-13503 Implant 21.2 Dose | Experimental | Drug: AR-13503 Implant 21.2 DoseSingle dose of AR-13503 Implant 21.2 Dose (21.2 µg) administered as intravitreal implants into a single eye of up to 6 subjects (3 nAMD and 3 DME) who will be followed for 24 weeks |
| AR-13503 Implant 42.4 Dose | Experimental | Drug: AR-13503 42.4 DoseSingle dose of AR-13503 Implant 42.4 Dose (42.4 µg) administered as intravitreal implants into a single eye of up to 6 subjects (3 nAMD and 3 DME) who will be followed for 24 weeks |
| AR-13503 Implant 63.6 Dose | Experimental | Drug: AR-13503 63.6 DoseDose of AR-13503 Implant 63.6 Dose (63.6 µg) administered into a single eye of up to 5 subjects (DME) who will be followed for 24 weeks. Subjects may qualify to receive an additional dose at Week 12. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- Use of intraocular or periocular corticosteroids within 6 months, aflibercept within 8 weeks, ranibizumab or bevacizumab within 6 weeks
- History of vitreoretinal surgery in the study eye
- High risk proliferative diabetic retinopathy in the study eye and related complications
- Structural damage to the center or the macula that is likely to preclude improvement in visual acuity in the study eye after resolution of the DME
- Media clarity insufficient to obtain quality fundus and OCT images 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-13503 Implant 10.6 DoseAR-13503 Implant 10.6 Dose (10.6 µg) administered as an intravitreal implant into a single eye | Drug | AR-13503 Implant 10.6 Dose |
| AR-13503 Implant 21.2 DoseAR-13503 Implant 21.2 Dose (21.2 µg) administered as intravitreal implants into a single eye | Drug | AR-13503 Implant 21.2 Dose |
| AR-13503 42.4 DoseAR-13503 Implant 42.4 Dose (42.4 µg) administered as intravitreal implants into a single eye | Drug | AR-13503 Implant 42.4 Dose |
| AR-13503 63.6 DoseAR-13503 Implant 63.6 Dose (63.6 µg) administered as intravitreal implants into a single eye | Drug | AR-13503 Implant 63.6 Dose |
Primary outcome
Number of ocular and non-ocular TEAEs
Time frame: 24 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- 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.
Kevin Kerr study director
Aerie Pharmaceuticals, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AR-13503 Implant 10.6 Dose, AR-13503 Implant 21.2 Dose and AR-13503 42.4 Dose in people with Neovascular Age-related Macular Degeneration and Diabetic Macular Edema, run by Aerie Pharmaceuticals at 6 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 0 inclusion and 11 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 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of ocular and non-ocular TEAEs (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2023.