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CLG561 Proof-of-Concept Study as a Monotherapy and in Combination With LFG316 in Subjects With Geographic Atrophy (GA)

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ClinicalTrials.gov Identifier: NCT02515942
Recruitment Status : Completed
First Posted : August 5, 2015
Results First Posted : December 18, 2018
Last Update Posted : May 30, 2019
Sponsor:
Collaborator:
Novartis Institutes for BioMedical Research
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of 12 (every 28 days) intravitreal (IVT) injections of CLG561 as a monotherapy and in combination with LFG316 as compared to sham in subjects with geographic atrophy.

Condition or disease Intervention/treatment Phase
Geographic Atrophy Drug: CLG561 Drug: LFG316 Drug: Sham injection Phase 2

Detailed Description:
This study consists of an up-to 30-day screening period, an approximately 336-day treatment period, and a follow-up period consisting of two visits occurring 4 and 16 weeks after the last administered injection.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized, Multi-Center, Single Masked, Sham Controlled, Proof-of-Concept Study of Intravitreal CLG561 as a Monotherapy and in Combination With LFG316 in Subjects With Geographic Atrophy
Actual Study Start Date : September 25, 2015
Actual Primary Completion Date : August 14, 2017
Actual Study Completion Date : December 1, 2017

Arm Intervention/treatment
Experimental: CLG561
CLG561 10 mg, one IVT injection every 28 days for a total of 12 injections
Drug: CLG561
Experimental: CLG561+LFG316
CLG561 5mg + LFG316 5 mg, one IVT injection every 28 days for a total of 12 injections
Drug: CLG561
Drug: LFG316
Sham Comparator: Sham Injection
One sham injection every 28 days for total of 12 sham injections
Drug: Sham injection
Empty syringe (without a needle) placed against the eye




Primary Outcome Measures :
  1. Number of Subjects With a Serious Adverse Event That, in the Opinion of the Investigator, is Related to the Study Drug [ Time Frame: Up to Day 421 ]
    A serious adverse event (SAE) was defined as any adverse experience that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. All SAEs related to the study drug are reported. No statistical analysis was conducted.

  2. Mean Change From Baseline in Intraocular Pressure (IOP) [ Time Frame: Baseline (Day 1), Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309 ]
    IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry and reported in millimeters of mercury (mmHg). A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). Baseline is defined as the last measurement prior to first dose of treatment. A more negative change indicates a greater amount of improvement. One eye (study eye) contributed to the analysis. No statistical analysis was conducted.

  3. Change in GA Lesion Size From Baseline to Day 337 as Measured by Fundus Autofluorescence (FAF) [ Time Frame: Baseline (Day 1), Day 337 ]
    Geographic atrophy, also known as atrophic age-related macular degeneration (AMD) or advanced dry AMD, is an advanced form of age-related macular degeneration that can result in the progressive and irreversible loss of retina which can lead to a loss of visual function over time. Geographic atrophy (GA) lesion size was assessed by a Central Reading Center (CRC) using FAF. Baseline is defined as the last measurement prior to first dose of treatment. One eye (study eye) contributed to the analysis.


Secondary Outcome Measures :
  1. Change in GA Lesion Size From Baseline to Day 85, 169, and 253 as Measured by FAF [ Time Frame: Baseline (Day 1), Day 85, Day 169, Day 253 ]
    Geographic atrophy, also known as atrophic age-related macular degeneration (AMD) or advanced dry AMD, is an advanced form of age-related macular degeneration that can result in the progressive and irreversible loss of retina which can lead to a loss of visual function over time. Geographic atrophy (GA) lesion size was assessed by a Central Reading Center (CRC) using FAF. Baseline is defined as the last measurement prior to first dose of treatment. One eye (study eye) contributed to the analysis.

  2. Mean Change in GA Lesion Size From Baseline to Day 421 as Measured by FAF [ Time Frame: Baseline (Day 1), Day 421 ]
    Geographic atrophy, also known as atrophic age-related macular degeneration (AMD) or advanced dry AMD, is an advanced form of age-related macular degeneration that can result in the progressive and irreversible loss of retina which can lead to a loss of visual function over time. Geographic atrophy (GA) lesion size was assessed by a Central Reading Center (CRC) using FAF. Baseline is defined as the last measurement prior to first dose of treatment. One eye (study eye) contributed to the analysis. Day 421 measurements were only summarized descriptively and did not include any statistical modeling.

  3. Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) [ Time Frame: Baseline (Day 1), Day 2, Day 8, Day 15, Day 29, Day 30, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309, Day 337 ]
    BCVA was assessed using ETDRS testing at 4 meters. Baseline is defined as the last measurement prior to first dose of treatment. BCVA change was defined as a change in letters read from the baseline assessment. A positive change value indicates improvement. One eye (study eye) contributed to the analysis.

  4. Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS [ Time Frame: Baseline (Day 1), Day 2, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309, Day 337 ]
    Low Luminance Visual Acuity (VA) was assessed using ETDRS testing at 4 meters with a neutral density filter to reduce chart luminance to 3 candelas/m2. Baseline is defined as the last measurement prior to first dose of treatment. BCVA change was defined as a change in letters read from the baseline assessment. A positive change value indicates improvement. One eye (study eye) contributed to the analysis.

  5. Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS [ Time Frame: Baseline (Day 1), Day 2, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309, Day 337 ]
    Low Luminance Visual Acuity (VA) was assessed using ETDRS testing at 4 meters with a neutral density filter to reduce chart luminance to 3 candelas/m2. A deficit in LLVA is defined as a loss in letters read from baseline. Baseline is defined as the last measurement prior to first dose of treatment. A negative change value indicates improvement (more letters read). One eye (study eye) contributed to the analysis.

  6. Average Change in BCVA From Baseline to the Period Day 281 to Day 337 as Measured by ETDRS [ Time Frame: Baseline (Day 1), Day 281, Day 309, Day 337 ]
    BCVA was assessed using ETDRS testing at 4 meters. Day 281, Day 309, and Day 337 were averaged and compared to baseline. BCVA change was defined as a change in letters read from the baseline assessment. A positive change value indicates improvement. One eye (study eye) contributed to the analysis. No statistical analysis was conducted.

  7. Average Change in LLVA From Baseline to the Period Day 281 to Day 337 as Measured by ETDRS [ Time Frame: Baseline (Day 1), Day 281, Day 309, Day 337 ]
    LLVA was assessed at 4 meters using a neutral density filter to reduce chart luminance to 3 candelas/m2. Baseline is defined as the last measurement prior to first dose of treatment. Day 281, Day 309, and Day 337 were averaged and compared to baseline. BCVA change was defined as a change in letters read from the baseline assessment. A positive change value indicates improvement. One eye (study eye) contributed to the analysis. No statistical analysis was conducted.

  8. Average LLVA Deficit (Letters) Change From Baseline at Day 281 to Day 337 as Measured by ETDRS [ Time Frame: Baseline (Day 1), Day 281, Day 309, Day 337 ]
    LLVA was assessed at 4 meters using a neutral density filter to reduce chart luminance to 3 candelas/m2. A deficit in LLVA is defined as a loss in letters read from baseline. Baseline is defined as the last measurement prior to first dose of treatment. Day 281, Day 309, and Day 337 were averaged and compared to baseline. A negative change value indicates improvement (more letters read). One eye (study eye) contributed to the analysis.

  9. Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS [ Time Frame: Baseline (Day 1), Day 2, Day 8, Day 15, Day 29, Day 30, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309, Day 337 ]
    BCVA was assessed using ETDRS testing at 4 meters. Baseline is defined as the last measurement prior to first dose of treatment. BCVA change was defined as a change in letters read from the baseline assessment and is reported categorically. One eye (study eye) contributed to the analysis. No statistical analysis was conducted.

  10. Total CLG561 Serum Concentrations up to Day 421 [ Time Frame: Baseline (Day 1), Day 2, Day 8, Day 15, Day 29, Day 85, Day 169, Day 253, Day 309, Day 337, Day 421 ]
    Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method.

  11. Total LFG316 Serum Concentration up to Day 421 [ Time Frame: Baseline (Day 1), Day 337, Day 421 ]
    Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method.

  12. Percentage of Subjects With Anti-CLG561 Antibodies up to Day 421 [ Time Frame: Baseline (Day 1), up to Day 421 ]
    Samples were collected and assessed for anti-CLG561 antibodies.

  13. Percentage of Subjects With Anti-LFG316 Antibodies up to Day 421 [ Time Frame: Baseline (Day 1), up to Day 421 ]
    Samples were collected and assessed for anti-LFG316 antibodies.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sign written informed consent form;
  • Geographic atrophy in both eyes;
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Pregnant or lactating women and women of child-bearing potential;
  • Any medical condition (systemic or ophthalmic) that may preclude the safe administration of test article or safe participation in this study;
  • Any contraindications or hypersensitivities to any component of the LFG316 or CLG561 solution;
  • Any contraindications to IVT injections;
  • Ocular surgery in either eye within 90 days of screening;
  • Uncontrolled ocular hypertension or glaucoma in the study eye;
  • Other protocol-specified exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02515942


Sponsors and Collaborators
Alcon Research
Novartis Institutes for BioMedical Research
Investigators
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Study Director: Sr Clinical Manager, Pharma, GCRA Alcon Research
  Study Documents (Full-Text)

Documents provided by Alcon Research:
Statistical Analysis Plan  [PDF] January 8, 2018
Study Protocol  [PDF] January 20, 2016


Additional Information:
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02515942     History of Changes
Other Study ID Numbers: CLG561-2201
CCLG561X2201 ( Other Identifier: Novartis Institutes for BioMedical Research )
First Posted: August 5, 2015    Key Record Dates
Results First Posted: December 18, 2018
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alcon Research:
Geographic atrophy (GA)
Macular degeneration
Dry age-related macular degeneration (AMD)
Intravitreal (IVT)
Retinal diseases
Fundus auto fluorescence (FAF)
Additional relevant MeSH terms:
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Geographic Atrophy
Atrophy
Pathological Conditions, Anatomical
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases