Geographic AtrophyPhase 2NCT01602120
An Extension Study to Evaluate the Long-Term Safety of Lampalizumab in Participants With Geographic Atrophy
A Phase 2 study testing Lampalizumab in people with Geographic Atrophy, run by Genentech, Inc. at 46 sites in 2 countries.
Trial summary
This is a multicenter, open-label extension study of safety and tolerability of lampalizumab administered by intravitreal (ITV) injection to participants with geographic atrophy (GA) who have completed the 18-month treatment in Study CFD4870g (GX01456) (NCT01229215) or 24-week treatment in Study GX29455 (NCT02288559). Read more about this study
- Who is it for?
- Ages 60 to 89 years
- Conditions the study is for
- Geographic Atrophy
- What is being tested?
- Lampalizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 46 sitesin 2 countries
- Study dates
- 29 May 2012to 9 Feb 2018
- 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 60 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For CFD4870g participants: Previous enrollment and completion (Month 18 visit) of Study CFD4870g without early treatment discontinuation (lampalizumab or sham)
- For GX29455 participants: Previous enrollment and completion (Week 24 visit) of Study GX29455 without early treatment discontinuation (lampalizumab or sham)
- Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit quality fundus imaging
Who cannot join
- Early treatment and/or study discontinuation prior to completion of study CFD4870g (GX01456) and GX29455
- Vitrectomy surgery, submacular surgery, or other surgical intervention for age-related macular degeneration (AMD) in the study eye
- Subfoveal focal laser photocoagulation in the study eye
- Treatment with Visodyne, external-beam radiation therapy, or transpupillary thermotherapy in the study eye
- Intravitreally (ITV) drug delivery (e.g., ITV corticosteroid injection, anti-angiogenic drugs, anticomplement drugs, or device implantation) in the study eye. Lampalizumab in study eye and ranibizumab in either eye are permitted
- Any concurrent ocular or intraocular condition in the study eye that contraindicates the use of an investigational drug or may affect interpretation of the study results or may render the participant at high risk for treatment complications
Trial locations and contacts
46 sites in 2 countries.
46 sites in 2 countries
United States41 sites
W Texas Retina Consultants PA
Abilene, Texas, 79606
Eye Associates of New Mexico
Albuquerque, New Mexico, 87102
Western Carolina Retinal Associate PA
Asheville, North Carolina, 28803
Southeast Retina Center
Augusta, Georgia, 30909
Retina Research Center
Austin, Texas, 78705
Elman Retina Group
Baltimore, Maryland, 21237
Retina Assoc of Cleveland Inc
Beachwood, Ohio, 44122
Retina-Vitreous Assoc Med Grp
Beverly Hills, California, 90211
Retina Group of Florida
Boca Raton, Florida, 33431
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
Retinal Diagnostic Center
Campbell, California, 95008
Char Eye Ear &Throat Assoc
Charlotte, North Carolina, 28210
Cincinnati Eye Institute
Cincinnati, Ohio, 45242
Texas Retina Associates
Dallas, Texas, 75231
Vitreoretinal Surgery
Edina, Minnesota, 55435
The Retina Partners
Encino, California, 91436
National Ophthalmic Research Institute
Fort Myers, Florida, 33912
Colorado Retina Associates, PC
Golden, Colorado, 80401
Southeastern Retina Associates
Knoxville, Tennessee, 37923
Charleston Neuroscience Institute
Ladson, South Carolina, 29456
Loma Linda University
Loma Linda, California, 92354
Opthalmic Consultants of LI
Lynbrook, New York, 11563
Florida Eye Associates
Melbourne, Florida, 32901
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Tennessee Retina PC
Nashville, Tennessee, 37203
Wagner Macula & Retina Center
Norfolk, Virginia, 23451
San Diego Retina Associates
Oceanside, California, 92056
Dean McGee Eye Institute
Oklahoma City, Oklahoma, 73099
Retina Care Specialists
Palm Beach Gardens, Florida, 33410
Retina Specialty Institute
Pensacola, Florida, 32503
Mid Atlantic Retina
Philadelphia, Pennsylvania, 19107
Retina Northwest
Portland, Oregon, 97221
Sierra Eye Associates
Reno, Nevada, 89502
W Coast Retina Med Group Inc
San Francisco, California, 94107
West Coast Retina
San Francisco, California, 94107
California Retina Consultants
Santa Barbara, California, 93103
The Retina Institute
St Louis, Missouri, 63128
Retina Macula Institute
Torrance, California, 90503
Retina Centers P.C.
Tucson, Arizona, 85704
Wolfe Eye Clinic
West Des Moines, Iowa, 50266
Ctr for Retina & Macular Dis
Winter Haven, Florida, 33880
Germany5 sites
Universitatsklinikum Bonn; Medizinische Klinik und Poliklinik III
Bonn, 53127
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106
Universitatsklinikum Leipzig
Leipzig, 04103
St. Franziskus Hospital
Münster, 48145
Universitätsklinikum Tübingen
Tübingen, 72076
About this study
Official title: A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Lampalizumab (FCFD4514S) in Patients With Geographic Atrophy Who Have Completed Genentech-Sponsored Lampalizumab Studies
This is a multicenter, open-label extension study of safety and tolerability of lampalizumab administered by intravitreal (ITV) injection to participants with geographic atrophy (GA) who have completed the 18-month treatment in Study CFD4870g (GX01456) (NCT01229215) or 24-week treatment in Study GX29455 (NCT02288559).
- Conditions
- Geographic Atrophy
- Being tested
- Lampalizumab
- Medical subject headings
- Geographic Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LampalizumabDrug
Also called FCFD4514S
Lampalizumab 10 mg ITV injections as per the schedule specified in respective arms.
| Study group | Role | What they receive |
|---|---|---|
| CFD4870g Sham | Experimental | Participants who were administered sham comparator in Study NCT01229215 (CFD4870g), will receive lampalizumab 10 milligrams (mg), intravitreally (ITV), either once in every 4 weeks (Q4W) or once in every 8 weeks (Q8W) in accordance with their previously assigned treatment frequency assignment in Study CFD4870g followed by Q4W administration for the remainder of the extension study up to approximately 96 months. Receives: Drug: Lampalizumab |
| CFD4870g Lampalizumab | Experimental | Participants will receive lampalizumab 10 mg, ITV, Q4W or Q8W in accordance with their previously assigned treatment frequency assignment in Study NCT01229215 (CFD4870g) followed by Q4W administration for the remainder of the extension study up to approximately 96 months. Receives: Drug: Lampalizumab |
| GX29455 Sham | Experimental | Participants who were administered sham comparator in Study NCT02288559 (GX29455), will receive lampalizumab 10 mg, ITV, Q4W throughout the extension study up to approximately 54 months. Receives: Drug: Lampalizumab |
| GX29455 Lampalizumab | Experimental | Participants who were administered lampalizumab in Study NCT02288559 (GX29455), will receive lampalizumab 10 mg, ITV, Q4W throughout the extension study up to approximately 54 months. Receives: Drug: Lampalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Ocular and Non-ocular Adverse Events (AEs)
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are events localized to the eye. Non-ocular events include all other events.
Measured: From Day 1 up to the last study visit (up to approximately 62 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study start29 May 2012
- Primary completion8 Nov 2017
- Study completion9 Feb 2018
Why it stopped: The study was terminated early by the Sponsor due to lack of efficacy.
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01602120
- Sponsor's protocol ID
- GX28198
- Other IDs
- 2012-000578-41
- Status last verified
- Sep 2019
- First submitted
- 16 May 2012
- Last updated
- 11 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Lampalizumab (FCFD4514S) in Patients With Geographic Atrophy Who Have Completed Genentech-Sponsored Lampalizumab Studies
- ClinicalTrials.gov ID
- NCT01602120
- Acronym / sponsor ID
- GX28198
- Conditions
- Geographic Atrophy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early by the Sponsor due to lack of efficacy.
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 May 2012 (actual)
- Primary completion
- 8 Nov 2017 (actual)
- Study completion
- 9 Feb 2018 (actual)
- First posted
- 18 May 2012 (estimated)
- Results
- Posted 21 Feb 2019
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 multicenter, open-label extension study of safety and tolerability of lampalizumab administered by intravitreal (ITV) injection to participants with geographic atrophy (GA) who have completed the 18-month treatment in Study CFD4870g (GX01456) (NCT01229215) or 24-week treatment in Study GX29455 (NCT02288559).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CFD4870g Sham | Experimental | Drug: LampalizumabParticipants who were administered sham comparator in Study NCT01229215 (CFD4870g), will receive lampalizumab 10 milligrams (mg), intravitreally (ITV), either once in every 4 weeks (Q4W) or once in every 8 weeks (Q8W) in accordance with their previously assigned treatment frequency assignment in Study CFD4870g followed by Q4W administration for the remainder of the extension study up to approximately 96 months. |
| CFD4870g Lampalizumab | Experimental | Drug: LampalizumabParticipants will receive lampalizumab 10 mg, ITV, Q4W or Q8W in accordance with their previously assigned treatment frequency assignment in Study NCT01229215 (CFD4870g) followed by Q4W administration for the remainder of the extension study up to approximately 96 months. |
| GX29455 Sham | Experimental | Drug: LampalizumabParticipants who were administered sham comparator in Study NCT02288559 (GX29455), will receive lampalizumab 10 mg, ITV, Q4W throughout the extension study up to approximately 54 months. |
| GX29455 Lampalizumab | Experimental | Drug: LampalizumabParticipants who were administered lampalizumab in Study NCT02288559 (GX29455), will receive lampalizumab 10 mg, ITV, Q4W throughout the extension study up to approximately 54 months. |
Who may qualify
- Ages
- 60 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- For CFD4870g participants: Previous enrollment and completion (Month 18 visit) of Study CFD4870g without early treatment discontinuation (lampalizumab or sham)
- For GX29455 participants: Previous enrollment and completion (Week 24 visit) of Study GX29455 without early treatment discontinuation (lampalizumab or sham)
- Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit quality fundus imaging
Key exclusion criteria (6 listed)
- Early treatment and/or study discontinuation prior to completion of study CFD4870g (GX01456) and GX29455
- Vitrectomy surgery, submacular surgery, or other surgical intervention for age-related macular degeneration (AMD) in the study eye
- Subfoveal focal laser photocoagulation in the study eye
- Treatment with Visodyne, external-beam radiation therapy, or transpupillary thermotherapy in the study eye
- Intravitreally (ITV) drug delivery (e.g., ITV corticosteroid injection, anti-angiogenic drugs, anticomplement drugs, or device implantation) in the study eye. Lampalizumab in study eye and ranibizumab in either eye are permitted
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 |
|---|---|---|
| LampalizumabAlso: FCFD4514SLampalizumab 10 mg ITV injections as per the schedule specified in respective arms. | Drug | CFD4870g Lampalizumab, CFD4870g Sham, GX29455 Lampalizumab, GX29455 Sham |
Primary outcome
Percentage of Participants With Ocular and Non-ocular Adverse Events (AEs)
Time frame: From Day 1 up to the last study visit (up to approximately 62 months)
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are events localized to the eye. Non-ocular events include all other events.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Clinical Trials study director
Genentech, Inc.
46 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lampalizumab in people with Geographic Atrophy, run by Genentech, Inc. at 46 sites in 2 countries.
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 6 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: stopped early, as of the sponsor's last update on 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States, Germany. 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 21 Feb 2019). 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?
Percentage of Participants With Ocular and Non-ocular Adverse Events (AEs) (time frame: From Day 1 up to the last study visit (up to approximately 62 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 11 Sep 2019.