Neovascular Age-elated Macular Degeneration (Wet AMD)Phase 2NCT01535950
Safety and Efficacy of Intravitreal LFG316 in Wet Age Related Macular Degeneration (AMD)
A Phase 2 study testing LFG316 in people with Neovascular Age-elated Macular Degeneration (Wet AMD) and Exudative Macular Degeneration, run by Novartis Pharmaceuticals at 7 sites in United States.
Trial summary
This study will assess the safety and efficacy of LFG316 in patients with age related macular degeneration. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Neovascular Age-elated Macular Degeneration (Wet AMD), Exudative Macular Degeneration
- What is being tested?
- LFG316
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 7 sitesUnited States
- Study dates
- Feb 2012to Jul 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
- Best corrected visual acuity (ETDRS scale) of 60 letters or less in the study eye.
- An active choroidal neovascular membrane attributable to neovascular AMD in at least one eye.
- History of treatment (at any time) with at least 3 doses of anti-VEGF therapy in the study eye.
Who cannot join
- History of recurrent non-response to anti-VEGF therapy in the study eye.
- In the study eye, retinal disease other than AMD (benign conditions of the vitreous and peripheral retina are not exclusionary).
- Choroidal neovascularization due to a cause other than AMD.
- In the study eye, media opacity that, in the investigator's opinion, could interfere with conduct of the study.
- History of infectious uveitis or endophthalmitis in either eye.
- Any of the following treatments to the study eye within 28 days prior to dosing: ranibizumab, bevacizumab, pegaptanib or other VEGF inhibitor.
- Any of the following within 90 days prior to dosing: photodynamic therapy or laser photocoagulation in the study eye; intravitreal steroid in the study eye; or intraocular surgery (including cataract surgery) in the study eye
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Novartis Investigative Site
Abilene, Texas, 79606
Novartis Investigative Site
Baltimore, Maryland, 21237-4350
Novartis Investigative Site
Fort Myers, Florida, 33912-7125
Novartis Investigative Site
Fort Worth, Texas, 76104
Novartis Investigative Site
Torrance, California, 90503
Novartis Investigative Site
Tucson, Arizona, 85704-5614
Novartis Investigative Site
West Columbia, South Carolina, 29169
About this study
Official title: A Multicenter, Randomized, Sham-controlled, Repeat-dose Study to Assess the Safety, Tolerability, Serum Pharmacokinetics, and Efficacy of Intravitreal LFG316 in Patients With Neovascular Age-related Macular Degeneration
This study will assess the safety and efficacy of LFG316 in patients with age related macular degeneration.
- Being tested
- LFG316, Placebo
- Keywords
- Age-related macular degeneration, intravitreal, neovascular, anti-vascular endothelial growth factor, wet AMD, Age-related, Macular degeneration, Intravitreal, Neovascular
- Medical subject headings
- Wet Macular Degeneration, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LFG316Drug
PlaceboDrug
Placebo will be administered as sham injections. Sham injections will involve placement of the syringe hub against the sclera, without use of a needle.
| Study group | Role | What they receive |
|---|---|---|
| LFG316 | Experimental | Not described Receives: Drug: LFG316 |
| Sham | Sham comparator | Not described Receives: Drug: Placebo |
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) retreatments vs time
Number or retreatments with anti-VEGF treatments will be recorded
Measured: Day 1 to 113
Secondary outcomes (5)
The proportion of patients in the study that requires at least one treatment of anti-VEGF medication.
Number or retreatments with anti-VEGF treatments will be recorded
Measured: Day 1 and 113
Effect of LFG316 on visual acuity
Early Treatment Diabetic Retinopathy Study" (ETDRS best corrected visual acuity measured under ESTDRS conditions Number of letters correctly read will be recorded.
Measured: Day 1 and 113
Effect of LFG316 on central retinal thickness and choroidal neovascular membrane area, and drusen area/volume where applicable
Summary statistics of these variables will be provided by treatment and visit/time. Treatment effect will be assessed by comparison of mean change from baseline to Day 85.
Measured: Day 1 , Day 85 and Day 113 (starting from the day of first IVT injection until end of study)
Serum concentrations of total LFG316 versus time
Blood samples will be collected
Measured: Days 1, 8, 15, 29, 43, 57, 71, 85 and 113
Number of patients with adverse events
Adverse events will be determined based on descriptive analyses of vital signs, electrocardiogram (ECG) evaluation, and clinical safety laboratory evaluations. All abnormalities will be flagged and summary statistics will be provided by treatment and visit/time.
Measured: Day 113
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-elated Macular Degeneration (Wet AMD)Studies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 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
- NCT01535950
- Sponsor's protocol ID
- CLFG316A2202
- Status last verified
- Mar 2016
- First submitted
- 10 Feb 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 Multicenter, Randomized, Sham-controlled, Repeat-dose Study to Assess the Safety, Tolerability, Serum Pharmacokinetics, and Efficacy of Intravitreal LFG316 in Patients With Neovascular Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT01535950
- Acronym / sponsor ID
- CLFG316A2202
- Keywords
- Age-related macular degeneration, intravitreal, neovascular, anti-vascular endothelial growth factor, wet AMD, Age-related, Macular degeneration, Intravitreal, Neovascular
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 20 Feb 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 and efficacy of LFG316 in patients with age related macular degeneration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LFG316 | Experimental | Drug: LFG316 |
| Sham | Sham comparator | Drug: Placebo |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Best corrected visual acuity (ETDRS scale) of 60 letters or less in the study eye.
- An active choroidal neovascular membrane attributable to neovascular AMD in at least one eye.
- History of treatment (at any time) with at least 3 doses of anti-VEGF therapy in the study eye.
Key exclusion criteria (7 listed)
- History of recurrent non-response to anti-VEGF therapy in the study eye.
- In the study eye, retinal disease other than AMD (benign conditions of the vitreous and peripheral retina are not exclusionary).
- Choroidal neovascularization due to a cause other than AMD.
- In the study eye, media opacity that, in the investigator's opinion, could interfere with conduct of the study.
- History of infectious uveitis or endophthalmitis in either 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 | Drug | LFG316 |
| PlaceboPlacebo will be administered as sham injections. Sham injections will involve placement of the syringe hub against the sclera, without use of a needle. | Drug | Sham |
Primary outcome
Number of anti-Vascular Endothelial Growth Factor (anti-VEGF) retreatments vs time
Time frame: Day 1 to 113
Number or retreatments with anti-VEGF treatments will be recorded
5 secondary outcomes
The proportion of patients in the study that requires at least one treatment of anti-VEGF medication.
Time frame: Day 1 and 113
Effect of LFG316 on visual acuity
Time frame: Day 1 and 113
Effect of LFG316 on central retinal thickness and choroidal neovascular membrane area, and drusen area/volume where applicable
Time frame: Day 1 , Day 85 and Day 113 (starting from the day of first IVT injection until end of study)
Serum concentrations of total LFG316 versus time
Time frame: Days 1, 8, 15, 29, 43, 57, 71, 85 and 113
Number of patients with adverse events
Time frame: Day 113
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 19 Dec 2020.
- Results for CLFG316A2202 from the Novartis Clinical Trials websiteLink provided by the sponsor.
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
7 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-elated Macular Degeneration (Wet AMD) and Exudative Macular Degeneration, run by Novartis Pharmaceuticals at 7 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 3 inclusion and 7 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 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 7 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 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?
Number of anti-Vascular Endothelial Growth Factor (anti-VEGF) retreatments vs time (time frame: Day 1 to 113). 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.