Dry Age-related Macular DegenerationPhase 2NCT04358471
Intravitreal AAVCAGsCD59 for Advanced Dry Age-related Macular Degeneration (AMD) With Geographic Atrophy (GA)
A Phase 2 study testing Intravitreal AAVCAGsCD59 in people with Dry Age-related Macular Degeneration and Geographic Atrophy, run by Hemera Biosciences.
Trial summary
Patients with advanced dry AMD with GA meeting inclusion criteria will be randomized in one eye in a 1:1:1 ratio comparing intravitreal high or low dose AAVCAGsCD59 with a sham injection. All enrolled subjects will be followed for 24 months to evaluate reduction in GA growth and safety of intravitreal AAVCAGsCD59. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dry Age-related Macular Degeneration, Geographic Atrophy, Gene Therapy
- What is being tested?
- Intravitreal AAVCAGsCD59
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2021to 1 Sep 2023
- Phase
- Phase 2
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Advanced dry AMD with GA in the study eye
- BCVA in the study eye of 80 or less ETDRS letters (Snellen equivalent 20/25 or worse)
- Total cumulative GA lesion size 2.5 mm2 to 12.5 mm2 in the study eye as confirmed by the reading center during the Screening Period.
Who cannot join
- GA secondary to non-AMD etiologies in the study eye (i.e. myopia, inherited retinal diseases).
- GA associated with the presence of an RPE rip.
- GA contiguous with peripapillary atrophy.
- Active CNV secondary to wet AMD in the study eye and currently receiving anti-VEGF ocular treatment within the previous 18 months.
- Subretinal fibrosis in the macula from CNV both clinically and imaged on SD-OCT in the macula.
- Previous macular laser photocoagulation (i.e. focal or grid laser for macular edema), photodynamic therapy (PDT), ocular/orbital radiation, laser to CNV, or subretinal surgery for CNV in the study eye.
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- History of conditions in the study eye which might alter visual acuity or interfere with study testing including proliferative diabetic retinopathy (PDR), clinically significant macular edema (CSME), central retinal vein occlusion (CRVO), hemi retinal vein occlusion (HRVO), macular branch retinal vein occlusion, and optic neuropathy.
- Active uncontrolled glaucoma with at least one of the following: IOP>30 mmHg despite maximum medical treatment with glaucoma medications, cup-to-disc ratio of >0.9, visual field defects secondary to glaucoma that involve the macula, or optic atrophy from glaucoma.
- Active acute or chronic infectious uveitis, retinitis, or conjunctivitis (excluding blepharitis)
About this study
Official title: A Phase 2 Multi-Center Trial Evaluating Intravitreal AAVCAGsCD59 Compared to Sham Injection for the Treatment of Advanced Dry Age-Related Macular Degeneration (AMD) With Geographic Atrophy (GA)
Patients with advanced dry AMD with GA meeting inclusion criteria will be randomized in one eye in a 1:1:1 ratio comparing intravitreal high or low dose AAVCAGsCD59 with a sham injection. All enrolled subjects will be followed for 24 months to evaluate reduction in GA growth and safety of intravitreal AAVCAGsCD59.
- Conditions
- Dry Age-related Macular Degeneration, Geographic Atrophy, Gene Therapy, Intravitreal Injection
- Being tested
- Intravitreal AAVCAGsCD59, Intravitreal Sham Injection
- Medical subject headings
- Geographic Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal AAVCAGsCD59Biological
Also called HMR59
AAVCAGsCD59 is administered as an intravitreal injection in the enrolled eye
Intravitreal Sham InjectionOther
Also called Sham
Sham injection mimics a real injection in the enrolled eye
| Study group | Role | What they receive |
|---|---|---|
| Intravitreal AAVCAGsCD59 1.071x10e12 vg Injection | Active comparator | Intravitreal AAVACGsCD59 at a dose of 1.071x10e12 vg administered once on Day 0 Receives: Biological: Intravitreal AAVCAGsCD59 |
| Intravitreal AAVCAGsCD59 3.56x10e11 vg Injection | Active comparator | Intravitreal AAVACGsCD59 at a dose of 3.56x10e11 vg administered once on Day 0 Receives: Biological: Intravitreal AAVCAGsCD59 |
| Sham Intravitreal Injection | Sham comparator | Intravitreal Sham injection administered once on Day 0 Receives: Other: Intravitreal Sham Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the change in Geographic Atrophy area (mm2) measured at Day 0 and compared to the measurement at Month 24
Geographic atrophy will be measured based on imaging of the retina
Measured: 24 Months
Secondary outcomes (2)
Incidence of conversion from dry to wet age-related macular degeneration
Measure the number of treated eyes in the sham and AAVCAGsCD59-treated arms that convert from dry to wet age-related macular degeneration
Measured: 24 Months
Change in visual acuity of the AAVCAGsCD59 treated eye
Visual acuity measured on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart will be compared at Day 0 and Month 24
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start31 Jul 2021 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Why it stopped: The AAVCAGsCD59 asset has been transferred to Janssen Research and Development LLC
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be assigned to low dose AAVCAGsCD59, high dose AAVCAGsCD59, or sham arm.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hemera Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04358471
- Sponsor's protocol ID
- HMR-2001
- Status last verified
- May 2021
- First submitted
- 22 Mar 2020
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Multi-Center Trial Evaluating Intravitreal AAVCAGsCD59 Compared to Sham Injection for the Treatment of Advanced Dry Age-Related Macular Degeneration (AMD) With Geographic Atrophy (GA)
- ClinicalTrials.gov ID
- NCT04358471
- Acronym / sponsor ID
- HMR-2001
- Conditions
- Dry Age-related Macular Degeneration, Geographic Atrophy, Gene Therapy, Intravitreal Injection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The AAVCAGsCD59 asset has been transferred to Janssen Research and Development LLC
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hemera BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2021 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 24 Apr 2020 (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.
Patients with advanced dry AMD with GA meeting inclusion criteria will be randomized in one eye in a 1:1:1 ratio comparing intravitreal high or low dose AAVCAGsCD59 with a sham injection. All enrolled subjects will be followed for 24 months to evaluate reduction in GA growth and safety of intravitreal AAVCAGsCD59.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Subjects will be assigned to low dose AAVCAGsCD59, high dose AAVCAGsCD59, or sham arm.
| Arm | Type | Receives |
|---|---|---|
| Intravitreal AAVCAGsCD59 1.071x10e12 vg Injection | Active comparator | Biological: Intravitreal AAVCAGsCD59Intravitreal AAVACGsCD59 at a dose of 1.071x10e12 vg administered once on Day 0 |
| Intravitreal AAVCAGsCD59 3.56x10e11 vg Injection | Active comparator | Biological: Intravitreal AAVCAGsCD59Intravitreal AAVACGsCD59 at a dose of 3.56x10e11 vg administered once on Day 0 |
| Sham Intravitreal Injection | Sham comparator | Other: Intravitreal Sham InjectionIntravitreal Sham injection administered once on Day 0 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Advanced dry AMD with GA in the study eye
- BCVA in the study eye of 80 or less ETDRS letters (Snellen equivalent 20/25 or worse)
- Total cumulative GA lesion size 2.5 mm2 to 12.5 mm2 in the study eye as confirmed by the reading center during the Screening Period.
Key exclusion criteria (9 listed)
- GA secondary to non-AMD etiologies in the study eye (i.e. myopia, inherited retinal diseases).
- GA associated with the presence of an RPE rip.
- GA contiguous with peripapillary atrophy.
- Active CNV secondary to wet AMD in the study eye and currently receiving anti-VEGF ocular treatment within the previous 18 months.
- Subretinal fibrosis in the macula from CNV both clinically and imaged on SD-OCT in the macula.
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 |
|---|---|---|
| Intravitreal AAVCAGsCD59Also: HMR59AAVCAGsCD59 is administered as an intravitreal injection in the enrolled eye | Biological | Intravitreal AAVCAGsCD59 1.071x10e12 vg Injection, Intravitreal AAVCAGsCD59 3.56x10e11 vg Injection |
| Intravitreal Sham InjectionAlso: ShamSham injection mimics a real injection in the enrolled eye | Other | Sham Intravitreal Injection |
Primary outcome
Evaluate the change in Geographic Atrophy area (mm2) measured at Day 0 and compared to the measurement at Month 24
Time frame: 24 Months
Geographic atrophy will be measured based on imaging of the retina
2 secondary outcomes
Incidence of conversion from dry to wet age-related macular degeneration
Time frame: 24 Months
Change in visual acuity of the AAVCAGsCD59 treated eye
Time frame: 24 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intravitreal AAVCAGsCD59 in people with Dry Age-related Macular Degeneration and Geographic Atrophy, run by Hemera Biosciences.
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 3 inclusion and 9 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: withdrawn, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Evaluate the change in Geographic Atrophy area (mm2) measured at Day 0 and compared to the measurement at Month 24 (time frame: 24 Months). 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 10 May 2021.