Neovascular Age-related Macular DegenerationPhase 2NCT01624636
Safety and Tolerability of Intravenous LFG316 in Wet Age-related Macular Degeneration (AMD).
A Phase 2 study testing LFG316 in people with Neovascular Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 3 sites in United States.
Trial summary
This study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of successive intravenous (IV) doses of LFG316 in eligible patients with neovascular age-related macular degeneration (AMD) Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Neovascular Age-related Macular Degeneration
- What is being tested?
- LFG316
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2012to May 2013
- 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 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active choroidal neovascular AMD in at least one eye.
Who cannot join
- Retinal disease other than AMD that, in the investigator's opinion, would interfere with safety or study conduct.
- Choroidal neovascularization due to a cause other than AMD.
- In the study eye, media opacity that, in the investigator's opinion, would interfere with study conduct.
- Any disease or concomitant (or recent) medication expected to cause systemic immunosuppression.
- History of meningococcal meningitis in the past 10 years, or any history of recurrent meningitis.
- History of hospitalization for pneumococcal pneumonia within the past 3 years.
Show all 9Show fewer
- History of serious systemic infection within the past 12 months.
- Any of the following treatments to the study eye within 7 days prior to study drug dosing: ranibizumab (Lucentis), bevacizumab (Avastin), pegaptanib (Macugen), or other VEGF inhibitor.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Novartis Investigative Site
Cleveland, Ohio, 44122
Novartis Investigative Site
Phoenix, Arizona, 85014
Novartis Investigative Site
Winter Haven, Florida, 33880
About this study
Official title: A Multiple Dose, Two-cohort Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Intravenous LFG316 in Patients With Neovascular Age-related Macular Degeneration
This study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of successive intravenous (IV) doses of LFG316 in eligible patients with neovascular age-related macular degeneration (AMD)
- Being tested
- Placebo, LFG316
- Keywords
- AMD, Age-related Macular Degeneration, Wet AMD, Neovascular AMD
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
LFG316Drug
LFG316Drug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| LFG316: 10 mg/kg (2 doses in cohort 1) | Experimental | Not described Receives: Drug: LFG316 |
| LFG316: 20 mg/kg (2 doses in cohort 1, 3 doses in cohort 2). | Experimental | Not described Receives: Drug: LFG316 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of anti-vascular endothelial growth factor (anti-VEGF) retreatment vs time
Number of retreatments with anti-VEGF treatments will be recorded.
Measured: Day 1 to Day 113 (starting from the day of dosing until the end of the study)
Number and percentage of patients with adverse events.
Adverse events will be determined based on descriptive analyses of vital signs, ECG evaluation, and clinical safety laboratory evaluations. All abnormalities will be flagged and summary statistics will be provided by treatment and visit/time.Will be tabulated by body system and preferred term with a breakdown by treatment.
Measured: Day 1 to Day 113 (starting from the day of dosing until the end of the study)
Secondary outcomes (4)
Effect of LFG316 on visual acuity
"Early Treatment Diabetic Retinopathy Study" (ETDRS best corrected visual acuity measured under ETDRS conditions). Number of letters correctly read will be recorded.
Measured: Day 1 to Day 113
Effect of LFG316 on central retinal thickness, choroidal neovascular membrane area and drusen volume.
summary statistics will be provided by treatment group, cohort and visit/time. Treatment effect will be assessed by comparison of mean change from baseline to Day 85 of patients who received or did not receive anti-VEGF therapy.
Measured: Day 1 to Day 113
Serum concentrations of total LFG316 versus time
Blood samples will be collected.
Measured: Days 1, 8, 15, 22, 29, 43, 57, 78, 85 and 113 for both cohorts.
Serum concentration of pharmacodynamic parameters (Weislab and C5) versus time
Blood samples will be collected.
Measured: screening and Days 1, 8, 15, 22, 29, 43, 57, 78, 85 and 113 (for both cohorts).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2012 (estimated)
- Study startDec 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 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
- NCT01624636
- Sponsor's protocol ID
- CLFG316A2201
- Status last verified
- Mar 2016
- First submitted
- 3 May 2012
- Last updated
- 19 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Dose, Two-cohort Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Intravenous LFG316 in Patients With Neovascular Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT01624636
- Acronym / sponsor ID
- CLFG316A2201
- Keywords
- AMD, Age-related Macular Degeneration, Wet AMD, Neovascular AMD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 21 Jun 2012 (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, pharmacokinetics, pharmacodynamics, and efficacy of successive intravenous (IV) doses of LFG316 in eligible patients with neovascular age-related macular degeneration (AMD)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| LFG316: 10 mg/kg (2 doses in cohort 1) | Experimental | Drug: LFG316 |
| LFG316: 20 mg/kg (2 doses in cohort 1, 3 doses in cohort 2). | Experimental | Drug: LFG316 |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Active choroidal neovascular AMD in at least one eye.
Key exclusion criteria (9 listed)
- Retinal disease other than AMD that, in the investigator's opinion, would interfere with safety or study conduct.
- Choroidal neovascularization due to a cause other than AMD.
- In the study eye, media opacity that, in the investigator's opinion, would interfere with study conduct.
- Any disease or concomitant (or recent) medication expected to cause systemic immunosuppression.
- History of meningococcal meningitis in the past 10 years, or any history of recurrent meningitis.
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 |
|---|---|---|
| Placebo | Drug | Placebo |
| LFG316 | Drug | LFG316: 10 mg/kg (2 doses in cohort 1) |
| LFG316 | Drug | LFG316: 20 mg/kg (2 doses in cohort 1, 3 doses in cohort 2). |
Primary outcome
Number of anti-vascular endothelial growth factor (anti-VEGF) retreatment vs time
Time frame: Day 1 to Day 113 (starting from the day of dosing until the end of the study)
Number of retreatments with anti-VEGF treatments will be recorded.
Number and percentage of patients with adverse events.
Time frame: Day 1 to Day 113 (starting from the day of dosing until the end of the study)
Adverse events will be determined based on descriptive analyses of vital signs, ECG evaluation, and clinical safety laboratory evaluations. All abnormalities will be flagged and summary statistics will be provided by treatment and visit/time.Will be tabulated by body system and preferred term with a breakdown by treatment.
4 secondary outcomes
Effect of LFG316 on visual acuity
Time frame: Day 1 to Day 113
Effect of LFG316 on central retinal thickness, choroidal neovascular membrane area and drusen volume.
Time frame: Day 1 to Day 113
Serum concentrations of total LFG316 versus time
Time frame: Days 1, 8, 15, 22, 29, 43, 57, 78, 85 and 113 for both cohorts.
Serum concentration of pharmacodynamic parameters (Weislab and C5) versus time
Time frame: screening and Days 1, 8, 15, 22, 29, 43, 57, 78, 85 and 113 (for both cohorts).
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Results for CLFG316A2201 from the Novartis Clinical Trials websiteLink provided by the sponsor.
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LFG316 in people with Neovascular Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 3 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 1 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: stopped early, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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 stopped early. Results are not available in the source record.
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?
Number of anti-vascular endothelial growth factor (anti-VEGF) retreatment vs time (time frame: Day 1 to Day 113 (starting from the day of dosing until the end of the study)). The study lists 2 primary outcomes in all. 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 19 Dec 2020.