Geographic AtrophyPhase 1NCT03295877
Safety and Tolerability Study of RO7171009 in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
A Phase 1 study testing RO7171009 in people with Geographic Atrophy, run by Genentech, Inc. at 13 sites in United States.
Trial summary
This Phase 1, open-label, multicenter study will investigate the safety and tolerability of RO7171009 following single and multiple intravitreal (ITV) administrations in patients with GA secondary to AMD. The study consists of two stages: Single Dose-Escalation (SAD) and Multiple-Dose (MD) stages. 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?
- RO7171009
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 13 sitesUnited States
- Study dates
- 21 Sep 2017to 20 Nov 2018
- 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
- Participants aged greater than or equal to (>/=) 50 years
- Well demarcated area(s) of GA secondary to AMD with no evidence of prior or active choroidal neovascularization (CNV) in study eye
Who cannot join
- Ocular Exclusion Criteria, Study Eye:
- History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
- Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, or proliferative diabetic retinopathy
- Prior treatment with Visudyne®, external beam radiation therapy (for intraocular conditions), or transpupillary thermotherapy
- Ocular Exclusion Criteria (Both Eyes):
- GA in either eye due to causes other than AMD
- Evidence of prior or active CNV
- Previous participation in interventional clinical trials for GA or dry AMD, except for vitamins and minerals, irrespective of the route of administration (i.e., ocular or systemic) within the last 6 months
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Western Carolina Retinal Associate PA
Asheville, North Carolina, 28803
California Retina Consultants
Bakersfield, California, 93309
Retina Consultants of Southern Colorado PC; Clinical Research Department
Colorado Springs, Colorado, 80909-1183
Georgia Retina PC
Marietta, Georgia, 30060
Florida Eye Associates
Melbourne, Florida, 32901
Northern California Retina Vitreous Associates
Mountain View, California, 94040
Tennessee Retina PC.
Nashville, Tennessee, 37203
Retina Specialty Institute
Pensacola, Florida, 32503
Sierra Eye Associates
Reno, Nevada, 89502
Retinal Consultants Med Group
Sacramento, California, 95825
California Retina Consultants
Santa Barbara, California, 93103
California Retina Consultants - Santa Maria
Santa Maria, California, 93454
The Retina Institute
St Louis, Missouri, 63128
About this study
Official title: A Phase I, Multicenter, Open-Label, Single-Dose, Dose-Escalation, and Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of RO7171009 in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
This Phase 1, open-label, multicenter study will investigate the safety and tolerability of RO7171009 following single and multiple intravitreal (ITV) administrations in patients with GA secondary to AMD. The study consists of two stages: Single Dose-Escalation (SAD) and Multiple-Dose (MD) stages.
- Conditions
- Geographic Atrophy
- Being tested
- RO7171009
- Medical subject headings
- Geographic Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7171009Drug
Patients will receive RO7171009 via ITV injection.
| Study group | Role | What they receive |
|---|---|---|
| RO7171009: SAD | Experimental | Patients will receive a single dose of RO7171009, in multiple escalating cohorts. Receives: Drug: RO7171009 |
| RO7171009: MD | Experimental | Patients will receive RO7171009 at maximum tolerated dose (MTD), identified during the SAD stage for three doses. Receives: Drug: RO7171009 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of the Study Drug: Rate of Adverse Events
Measured: Through study completion or early study discontinuation (overall 12-20 weeks)
Secondary outcomes (1)
Serum Concentration of RO7171009
Measured: Through study completion or early study discontinuation (overall 12-20 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start21 Sep 2017
- Primary completion20 Nov 2018
- Study completion20 Nov 2018
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.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295877
- Sponsor's protocol ID
- GR39821
- Status last verified
- Feb 2020
- First submitted
- 19 Sep 2017
- Last updated
- 12 Feb 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multicenter, Open-Label, Single-Dose, Dose-Escalation, and Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of RO7171009 in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT03295877
- Acronym / sponsor ID
- GR39821
- Conditions
- Geographic Atrophy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 20 Nov 2018 (actual)
- Study completion
- 20 Nov 2018 (actual)
- First posted
- 28 Sep 2017 (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 Phase 1, open-label, multicenter study will investigate the safety and tolerability of RO7171009 following single and multiple intravitreal (ITV) administrations in patients with GA secondary to AMD. The study consists of two stages: Single Dose-Escalation (SAD) and Multiple-Dose (MD) stages.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RO7171009: SAD | Experimental | Drug: RO7171009Patients will receive a single dose of RO7171009, in multiple escalating cohorts. |
| RO7171009: MD | Experimental | Drug: RO7171009Patients will receive RO7171009 at maximum tolerated dose (MTD), identified during the SAD stage for three doses. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants aged greater than or equal to (>/=) 50 years
- Well demarcated area(s) of GA secondary to AMD with no evidence of prior or active choroidal neovascularization (CNV) in study eye
Key exclusion criteria (8 listed)
- History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
- Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, or proliferative diabetic retinopathy
- Prior treatment with Visudyne®, external beam radiation therapy (for intraocular conditions), or transpupillary thermotherapy
- GA in either eye due to causes other than AMD
- Evidence of prior or active CNV
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 |
|---|---|---|
| RO7171009Patients will receive RO7171009 via ITV injection. | Drug | RO7171009: MD, RO7171009: SAD |
Primary outcome
Safety and Tolerability of the Study Drug: Rate of Adverse Events
Time frame: Through study completion or early study discontinuation (overall 12-20 weeks)
1 secondary outcome
Serum Concentration of RO7171009
Time frame: Through study completion or early study discontinuation (overall 12-20 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 12 Feb 2020.
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RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
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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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Phase 1 Study of C.001 in Retinal Degeneration
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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.
Clinical Trials study director
Hoffmann-La Roche
13 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 RO7171009 in people with Geographic Atrophy, run by Genentech, Inc. at 13 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 8 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 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
Safety and Tolerability of the Study Drug: Rate of Adverse Events (time frame: Through study completion or early study discontinuation (overall 12-20 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 12 Feb 2020.