Geographic AtrophyPhase 1NCT04014777
Study of NGM621 in Participants With Geographic Atrophy
A Phase 1 study testing NGM621 in people with Geographic Atrophy, run by NGM Biopharmaceuticals, Inc at 6 sites in United States.
Trial summary
This is a multi-center evaluation of NGM621 in an open-label, single-dose and multiple-dose escalation study in participants with Geographic Atrophy secondary to Age-related Macular Degeneration. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Geographic Atrophy
- What is being tested?
- NGM621
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 6 sitesUnited States
- Study dates
- 26 Jul 2019to 27 May 2020
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- GA lesion size in the study eye of >=2.5 mm² as assessed by the central reading center
- BCVA - 54 to 4 letters (20/80 to 20/400 Snellen equivalent) using the standard ETDRS (Early Treatment of Diabetic Retinopathy Study) in the study eye at the Screening and Baseline visits; the fellow eye must have a BCVA of at least 69 letters (Snellen equivalent 20/40) at the Screening and Baseline visits
Who cannot join
- GA in either eye because of cause other than AMD
- History or evidence of glaucoma or ocular hypertension in either eye as defined by investigator
- Visual impairment in the study eye due to causes other than GA
- Spherical equivalent of the refractive error in the study eye demonstrating more than -6 Diopters of myopia (prior to cataract or refractive surgery)
- Other protocol-defined inclusion/exclusion criteria could apply.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
NGM Clinical Study Site
Arcadia, California, 91007
NGM Clinical Study Site
Austin, Texas, 78705
NGM Clinical Study Site
Melbourne, Florida, 32901
NGM Clinical Study Site
Newport Beach, California, 92663
NGM Clinical Study Site
St. Petersburg, Florida, 33711
NGM Clinical Study Site
The Woodlands, Texas, 77384
About this study
Official title: A Phase 1, Multicenter, Open-Label, Single-Dose and Multiple-Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravitreal Injections of NGM621 in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
This is a multi-center evaluation of NGM621 in an open-label, single-dose and multiple-dose escalation study in participants with Geographic Atrophy secondary to Age-related Macular Degeneration.
- Conditions
- Geographic Atrophy
- Being tested
- NGM621
- Medical subject headings
- Geographic Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGM621Biological
NGM621 Dose 1
NGM621Biological
NGM621 Dose 2
NGM621Biological
NGM621 Dose 3
NGM621Biological
NGM621 Dose 4
| Study group | Role | What they receive |
|---|---|---|
| NGM621 Cohort 1 Single Ascending Dose | Experimental | NGM621 single IVT injection Cohort-Dose 1 Receives: Biological: NGM621 |
| NGM621 Cohort 2 Single Ascending Dose | Experimental | NGM621 single IVT injection Cohort--Dose 2 Receives: Biological: NGM621 |
| NGM621 Cohort 3 Single Ascending Dose | Experimental | NGM621 single IVT injection Cohort--Dose 3 Receives: Biological: NGM621 |
| NGM621 Cohort 4 Multiple Dose | Experimental | NGM621 multiple IVT injection Cohort--Dose 4 Receives: Biological: NGM621 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Ocular and Systemic Treatment-Emergent Adverse Events (TEAEs)
The number and percent of patients reporting treatment emergent adverse events (TEAEs) by cohort.
Measured: 12 weeks
Secondary outcomes (1)
Serum Concentration of NGM621
Individual and mean serum NGM621 concentration data by cohort.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start26 Jul 2019
- Primary completion27 May 2020
- Study completion27 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geographic AtrophyStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- NGM Biopharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- NGM Study Director, Study director, NGM Biopharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04014777
- Sponsor's protocol ID
- 18-0501
- Status last verified
- Sep 2020
- First submitted
- 3 Jul 2019
- Last updated
- 1 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Open-Label, Single-Dose and Multiple-Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravitreal Injections of NGM621 in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT04014777
- Acronym / sponsor ID
- 18-0501
- Conditions
- Geographic Atrophy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- NGM Biopharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 26 Jul 2019 (actual)
- Primary completion
- 27 May 2020 (actual)
- Study completion
- 27 May 2020 (actual)
- First posted
- 10 Jul 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.
This is a multi-center evaluation of NGM621 in an open-label, single-dose and multiple-dose escalation study in participants with Geographic Atrophy secondary to Age-related Macular Degeneration.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NGM621 Cohort 1 Single Ascending Dose | Experimental | Biological: NGM621NGM621 single IVT injection Cohort-Dose 1 |
| NGM621 Cohort 2 Single Ascending Dose | Experimental | Biological: NGM621NGM621 single IVT injection Cohort--Dose 2 |
| NGM621 Cohort 3 Single Ascending Dose | Experimental | Biological: NGM621NGM621 single IVT injection Cohort--Dose 3 |
| NGM621 Cohort 4 Multiple Dose | Experimental | Biological: NGM621NGM621 multiple IVT injection Cohort--Dose 4 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- GA lesion size in the study eye of >=2.5 mm² as assessed by the central reading center
- BCVA - 54 to 4 letters (20/80 to 20/400 Snellen equivalent) using the standard ETDRS (Early Treatment of Diabetic Retinopathy Study) in the study eye at the Screening and Baseline visits; the fellow eye must have a BCVA of at least 69 letters (Snellen equivalent 20/40) at the Screening and Baseline visits
Key exclusion criteria (5 listed)
- GA in either eye because of cause other than AMD
- History or evidence of glaucoma or ocular hypertension in either eye as defined by investigator
- Visual impairment in the study eye due to causes other than GA
- Spherical equivalent of the refractive error in the study eye demonstrating more than -6 Diopters of myopia (prior to cataract or refractive surgery)
- Other protocol-defined inclusion/exclusion criteria could apply.
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 |
|---|---|---|
| NGM621NGM621 Dose 1 | Biological | NGM621 Cohort 1 Single Ascending Dose |
| NGM621NGM621 Dose 2 | Biological | NGM621 Cohort 2 Single Ascending Dose |
| NGM621NGM621 Dose 3 | Biological | NGM621 Cohort 3 Single Ascending Dose |
| NGM621NGM621 Dose 4 | Biological | NGM621 Cohort 4 Multiple Dose |
Primary outcome
Incidence and Severity of Ocular and Systemic Treatment-Emergent Adverse Events (TEAEs)
Time frame: 12 weeks
The number and percent of patients reporting treatment emergent adverse events (TEAEs) by cohort.
1 secondary outcome
Serum Concentration of NGM621
Time frame: 12 weeks
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 1 Oct 2020.
Related trials for Geographic Atrophy
Active, not recruitingPhase 1/2
Phase 1/2 Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
Age-Related Macular Degeneration, Geographic Atrophy
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingPhase 3
A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy
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RecruitingPhase 1
Phase 1 Study of C.001 in Retinal Degeneration
Geographic Atrophy, Stargardt Disease
RecruitingPhase 2/3
A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
Geographic Atrophy, Macular Degeneration
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.
NGM Study Director study director
NGM Biopharmaceuticals
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 NGM621 in people with Geographic Atrophy, run by NGM Biopharmaceuticals, Inc 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 2 inclusion and 5 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 1 Oct 2020. 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?
Incidence and Severity of Ocular and Systemic Treatment-Emergent Adverse Events (TEAEs) (time frame: 12 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 1 Oct 2020.