Advanced Age-related Macular DegenerationPhase 1NCT01255462
Intravitreal LFG316 in Patients With Advanced Age-related Macular Degeneration
A Phase 1 study testing LFG316 in people with Advanced Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 8 sites in United States.
Trial summary
This study will assess the safety, tolerability, and serum pharmacokinetics of intravitreal LFG316 in patients with advanced age-related macular degeneration. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Advanced Age-related Macular Degeneration
- What is being tested?
- LFG316
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 8 sitesUnited States
- Study dates
- Nov 2010to Sep 2011
- 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 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female AMD patients 55 to 90 years old, inclusive. In either eye, diagnosis of geographic atrophy or choroidal neovascularization due to AMD
- ETDRS best corrected visual acuity of 60 letters or worse in the study eye.
Who cannot join
- Retinal disease other than AMD in study eye which, in the investigator's opinion, may pose a safety risk or interfere with the study.
- Choroidal neovascularization due to a cause other than AMD.
- In the study eye, media opacity that interferes with fundus imaging or is likely to require surgery during the study period.
- Any of the following treatments to the study eye within 14 days prior to dosing: ranibizumab (Lucentis), bevacizumab (Avastin), pegaptanib (Macugen), or other VEGF inhibitor; OR likely requirement for one of the above treatments within 14 days of LFG316 administration.
- Any of the following within 30 days prior to dosing: photodynamic therapy treatment in the study eye; extrafoveal or juxtafoveal thermal laser photocoagulation in the study eye; systemic or topical (ophthalmic) steroid use in the study eye; bacterial keratitis in the study eye; OR intraocular surgery (including cataract surgery) in the fellow eye.
- Any of the following within 90 days prior to dosing: intraocular surgery (including cataract surgery) in the study eye; OR intravitreal or periocular corticosteroid injection in the study eye.
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- Participation in another interventional clinical study, or use of any experimental treatment for AMD or any other investigational new drug within 12 weeks prior to the start of study treatment. Clinical trials solely involving over-the-counter vitamins, supplements, or diets will not exclude the patients from study participation.
- Any medical condition likely to interfere with the patient's participation in the study, or likely to cause serious adverse events during the study.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Retina-Vitreous Associates Medical Group,
Beverly Hills, California, 90211
Opthalmic Consultants of Boston
Boston, Massachusetts, 02114
Charlotte Eye, Ear, Nose and Throat Associates
Charlotte, North Carolina, 28210
Texas Retina Associates
Dallas, Texas, 75231
National Ophthalmic Research Institute
Fort Myers, Florida, 33912
Retina Consultants of Houston
Houston, Texas, 77030
Retinal Consultants of Arizona,
Phoenix, Arizona, 85014
Center for Retina and Macular Disease
Winter Haven, Florida, 33880
About this study
Official title: A Multicenter, Open Label, Single Ascending Dose Study to Assess the Safety, Tolerability, and Serum Pharmacokinetics of Intravitreal LFG316 in Patients With Advanced Age-related Macular Degeneration
This study will assess the safety, tolerability, and serum pharmacokinetics of intravitreal LFG316 in patients with advanced age-related macular degeneration.
- Being tested
- LFG316
- Keywords
- AMD,, ARMD,, Age-related Macular Degeneration,, Eye Disease,, Wet AMD,, Neovascular AMD,, Choroidal Neovascular Membrane,, Choroidal Neovascularization,, Drusen,, Geographic Atrophy,, Complement,, C5,, Antibody
- Medical subject headings
- Macular Degeneration, Eye Diseases, Choroidal Neovascularization, Geographic Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LFG316Biological
LFG316Biological
LFG316Biological
LFG316Biological
| Study group | Role | What they receive |
|---|---|---|
| LFG316 0.15mg | Experimental | Not described Receives: Biological: LFG316 |
| LFG316 0.5mg | Experimental | Not described Receives: Biological: LFG316 |
| LFG316 1.5mg | Experimental | Not described Receives: Biological: LFG316 |
| LFG316 5mg | Experimental | Not described Receives: Biological: LFG316 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of single intravitreal doses of LFG316 in patients with advanced age-related macular degeneration.
Measured: Day 1 to Day 85 (starting from the day of intravitreal injection until the end of the study)
Secondary outcomes (1)
To evaluate the serum pharmacokinetic profile of single intravitreal doses of LFG316 in patients with advanced age-related macular degeneration.
Measured: Day 1 to Day 85 (starting from the day of intravitreal injection until the end of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01255462
- Sponsor's protocol ID
- CLFG316A2102
- Status last verified
- Apr 2012
- First submitted
- 6 Dec 2010
- Last updated
- 1 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open Label, Single Ascending Dose Study to Assess the Safety, Tolerability, and Serum Pharmacokinetics of Intravitreal LFG316 in Patients With Advanced Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT01255462
- Acronym / sponsor ID
- CLFG316A2102
- Keywords
- AMD,, ARMD,, Age-related Macular Degeneration,, Eye Disease,, Wet AMD,, Neovascular AMD,, Choroidal Neovascular Membrane,, Choroidal Neovascularization,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 7 Dec 2010 (estimated)
- 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 study will assess the safety, tolerability, and serum pharmacokinetics of intravitreal LFG316 in patients with advanced age-related macular degeneration.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LFG316 0.15mg | Experimental | Biological: LFG316 |
| LFG316 0.5mg | Experimental | Biological: LFG316 |
| LFG316 1.5mg | Experimental | Biological: LFG316 |
| LFG316 5mg | Experimental | Biological: LFG316 |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female AMD patients 55 to 90 years old, inclusive. In either eye, diagnosis of geographic atrophy or choroidal neovascularization due to AMD
- ETDRS best corrected visual acuity of 60 letters or worse in the study eye.
Key exclusion criteria (9 listed)
- Retinal disease other than AMD in study eye which, in the investigator's opinion, may pose a safety risk or interfere with the study.
- Choroidal neovascularization due to a cause other than AMD.
- In the study eye, media opacity that interferes with fundus imaging or is likely to require surgery during the study period.
- Any of the following treatments to the study eye within 14 days prior to dosing: ranibizumab (Lucentis), bevacizumab (Avastin), pegaptanib (Macugen), or other VEGF inhibitor; OR likely requirement for one of the above treatments within 14 days of LFG316 administration.
- Any of the following within 30 days prior to dosing: photodynamic therapy treatment in the study eye; extrafoveal or juxtafoveal thermal laser photocoagulation in the study eye; systemic or topical (ophthalmic) steroid use in the study eye; bacterial keratitis in the study eye; OR intraocular surgery (including cataract surgery) in the fellow 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 |
|---|---|---|
| LFG316 | Biological | LFG316 0.15mg |
| LFG316 | Biological | LFG316 0.5mg |
| LFG316 | Biological | LFG316 1.5mg |
| LFG316 | Biological | LFG316 5mg |
Primary outcome
To evaluate the safety and tolerability of single intravitreal doses of LFG316 in patients with advanced age-related macular degeneration.
Time frame: Day 1 to Day 85 (starting from the day of intravitreal injection until the end of the study)
1 secondary outcome
To evaluate the serum pharmacokinetic profile of single intravitreal doses of LFG316 in patients with advanced age-related macular degeneration.
Time frame: Day 1 to Day 85 (starting from the day of intravitreal injection until the end of the study)
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 May 2012.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
8 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 LFG316 in people with Advanced Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 8 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 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: finished, as of the sponsor's last update on 1 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
To evaluate the safety and tolerability of single intravitreal doses of LFG316 in patients with advanced age-related macular degeneration. (time frame: Day 1 to Day 85 (starting from the day of intravitreal injection until the end of the study)). 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 May 2012.