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Geographic AtrophyPhase 2NCT01527500

Intravitreal LFG316 in Patients With Age-related Macular Degeneration (AMD)

A Phase 2 study testing LFG316 and LFG316 Lower dose in people with Geographic Atrophy and Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 19 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study was conducted in two parts; Part A and Part B: Part B was initially planned to include two cohorts. Cohort 2 was cancelled following an interim analysis for efficacy in Part A of the study, and not due to any safety issues or concerns. Read more about this study

Who is it for?
Ages 55 years and older
What is being tested?
LFG316 and LFG316 Lower dose
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
158 participants
Where
19 sitesUnited States
Study dates
25 Jan 2012to 24 Jun 2015
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 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of AMD if enrolled in Part B of study
  • Geographic atrophy in at least one eye if enrolled in Part A of study
  • ETDRS best corrected visual acuity of 60 letters or worse (~≤ 20/63)

Who cannot join

  • Retinal disease other than AMD
  • History of choroidal neovascularization
  • Severe cataract
  • History of infectious uveitis or endophthalmitis
  • Eye surgery in the non-study eye within 30 days prior to study
  • Eye surgery or IVT injection in the study eye within 90 days prior to study
  • Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

United States19 sites

  • Novartis Investigative Site

    Atlanta, Georgia, 30342

  • Novartis Investigative Site

    Beverly Hills, California, 90211

  • Novartis Investigative Site

    Boston, Massachusetts, 02114

  • Novartis Investigative Site

    Charlotte, North Carolina, 28210

  • Novartis Investigative Site

    Cincinnati, Ohio, 45242

  • Novartis Investigative Site

    Cleveland, Ohio, 44122

  • Novartis Investigative Site

    Colorado Springs, Colorado, 80909

  • Novartis Investigative Site

    Fort Myers, Florida, 33912-7125

  • Novartis Investigative Site

    Grand Rapids, Michigan, 49546

  • Novartis Investigative Site

    Jackson, Michigan, 49202

  • Novartis Investigative Site

    Leawood, Kansas, 66211

  • Novartis Investigative Site

    Miami, Florida, 33143

  • Novartis Investigative Site

    Pasadena, California, 91105-3153

  • Novartis Investigative Site

    Phoenix, Arizona, 85014

  • Novartis Investigative Site

    Phoenix, Arizona, 85020

  • Novartis Investigative Site

    Sacramento, California, 95841

  • Novartis Investigative Site

    Silverdale, Washington, 98383

  • Novartis Investigative Site

    Tucson, Arizona, 85704-5614

  • Novartis Investigative Site

    Winter Haven, Florida, 33880

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Sham-control, Proof-of-concept Study of Intravitreal LFG316 in Patients With Geographic Atrophy Associated With Age-related Macular Degeneration

This study was conducted in two parts; Part A and Part B: Part B was initially planned to include two cohorts. Cohort 2 was cancelled following an interim analysis for efficacy in Part A of the study, and not due to any safety issues or concerns. Cohort 2 is not referred to again and part B cohort 1 is referred to as part B alone in the remainder of the document and is the subject of this report.

Part B was conducted to assess the safety and tolerability of a single intravitreal (IVT) LFG316 10 mg/100 µL injection. There was no efficacy evaluation in Part B. The study employed a multicenter, randomized, sham - controlled, single masked design. Eight patients with advanced AMD were planned to be randomized in a 3:1 ratio to receive a single IVT dose of LFG316 (10 mg/100 µL) or sham injection. Patients assigned to a sham injection were treated the same as those assigned to LFG316, except that the hub of an empty syringe (without needle) was placed against the eye instead of the IVT injection.

Being tested
LFG316, Sham, LFG316 Lower dose
Keywords
AMD, Age-related Macular Degeneration, geographic atrophy, GA, Dry AMD, Blindness, Drusen, GA lesion
Medical subject headings
Geographic Atrophy, Macular Degeneration, Blindness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LFG316Drug

    LFG316 5 mg/50 μL solution for IVT injection,

  • ShamDrug

    Sham injection (akin to intravitreal injection but without intravitreal needle; no investigational drug given)

  • LFG316 Lower doseDrug

    LFG316 5 mg/50 μL solution for IVT Injection

Study groups in NCT01527500
Study groupRoleWhat they receive
LFG316 higher doseExperimentalLFG316 10 mg/100 μL
Receives: Drug: LFG316
ShamSham comparatorSham injection
Receives: Drug: Sham
LFG316 lower doseExperimentalLFG316 5 mg/ 50 μL
Receives: Drug: LFG316 Lower dose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Geographic Atrophy (GA) Lesion Growth Measured by Fundus Autofluorescence (FAF) From Baseline to Day 505

    Geographic atrophy (GA) lesion growth measured by fundus autofluorescence (FAF) from baseline to Day 505.

    Measured: Day 1 to Day 505 (starting from the day of first intravitreal injection until Day 505)

  2. Part A: Sensitivity Analysis of the Primary End Point: Mixed Effects Model for Repeated Measurements on GA Lesion Growth Measured by Fundus Autoflourescence

    Number is the Estimated Difference (95% CI) in lesion size.

    Measured: The primary objective was from Day 1 to Day 337, however data was captured to Day 505 as exploratory objective

  3. Part B: Safety and Tolerability of a Single Intravitreal (IVT) Dose of 10 mg/100 μL of LFG316 in Patients With Advanced AMD).

    This primary outcome (for Part B) is reported under the Adverse Events section.

    Measured: Day 1 to Day 85

Secondary outcomes (9)

  1. Part A: Change From Baseline in GA Lesions Growth Measured by Fundus Autofluorescence

    Mean change in GA lesion growth from baseline to Day 169 and Day 505.

    Measured: Day 1 to Day 169 and Day 505 (starting from the day of first intravitreal injection until Day 505)

  2. Part A: Change in Best Corrected Visual Acuity (BCVA) as Measured by the EDTRS (Early Treatment of Diabetic Retinopathy Study) Scale From Baseline to Days 169, 337 & 505 in Patients Receiving Every 28 Days, Successive IVT Doses of LFG316 Compared to Sham

    Part A: Summary of best corrected visual acuity over time, statistical analysis of change in best corrected visual acuity over time Parameter: Visual Acuity (EDTRS letter) BCVA scale is 0-100, worst is 0 and best 100 Eye: STUDY

    Measured: Baseline Day 1, Day 169, Day 337 to Day 505

  3. Part A: Summary of Best Corrected Visual Acuity Over Time, Statistical Analysis of Change in Best Corrected Visual Acuity Over Time Parameter: Visual Acuity (EDTRS Letter) BCVA Scale is 0-100, Worst is 0 and Best 100 Eye: FELLOW

    Part A: Summary of best corrected visual acuity over time, statistical analysis of change in best corrected visual acuity over time Parameter: Visual Acuity (EDTRS letter) BCVA scale is 0-100, worst is 0 and best 100 Eye: FELLOW

    Measured: Baseline Day 1, Day 169, Day 337 to Day 505

  4. Part A: Concentrations of Total LFG316 in Blood During the Course of the Study

    Summary statistic of total LFG316 concentrations (pharmacokinetic analysis set)

    n=number of participants, h=hours after the last administered dose e.g.; 0.0 means just before dosing. If the mean concentration is 0.00, that means there is no drug in the bloodstream

    Measured: Day 1 to Day 559 (starting from the day of first intravitreal injection to day 559)

  5. Part A: Concentrations of Total C5 in Blood During the Course of the Study

    Summary statistic of total C5 concentrations n=number of participants, h=scheduled sampling time

    Measured: Day 1 to Day 559 (starting from the day of first intravitreal injection to day 559)

  6. Part B: AUC (Area Under the Curve) - Summary Statistics for PK Parameters

    Summary statistic of total LFG316 concentrations (pharmacokinetic analysis set)

    n=number of participants, h=scheduled sampling time

    Measured: Day 1 to Day 85 (starting from the day of first intravitreal injection to day 85)

  7. Tmax (hr)

    PART B: Tmax (Time of Maximum concentration observed)

    This is the highest concentration of drug in the blood that is measured after a dose. Cmax usually happens within a few hours after the dose is taken. The time that Cmax happens is referred to as Tmax. For some antiretroviral drugs, a high Cmax is thought to increase the risk of side effects from the drug.

    Measured: Day 1 to Day 85 (starting from the day of first intravitreal injection to day 85)

  8. Part B: Cmax - Summary Statistic for PK Parameters

    Summary statistic for Part B of total LFG316 concentrations (pharmacokinetic analysis set) Cmax is the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and before the administration of a second dose

    Measured: Day 1 to Day 85 (starting from the day of first intravitreal injection to day 85)

  9. Part B: Cmax_D - Summary Statistic for PK Parameters

    Cmax_D=ng/mL/mg

    Measured: Day 1 to Day 85 (starting from the day of first intravitreal injection to day 85)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2012 (estimated)
  2. Study start25 Jan 2012
  3. Primary completion24 Jun 2015
  4. Study completion24 Jun 2015

Resources

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
158 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01527500
Sponsor's protocol ID
CLFG316A2203
Status last verified
Mar 2019
First submitted
2 Feb 2012
Last updated
5 Jan 2021
Data monitoring committee
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Publications

  • Tzoumas N, Riding G, Williams MA, Steel DH. Complement inhibitors for age-related macular degeneration. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD009300. doi: 10.1002/14651858.CD009300.pub3.

    PubMed 37314061

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LFG316 and LFG316 Lower dose in people with Geographic Atrophy and Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 19 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 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 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?

Yes. Results are posted in the registry (first posted 27 Jul 2018). 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?

Part A: Geographic Atrophy (GA) Lesion Growth Measured by Fundus Autofluorescence (FAF) From Baseline to Day 505 (time frame: Day 1 to Day 505 (starting from the day of first intravitreal injection until Day 505)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01527500, which also lists 1 linked publication.

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 5 Jan 2021.

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