ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02515942
Recruitment Status : Completed
First Posted : August 5, 2015
Last Update Posted : December 7, 2017
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.

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 2017
Actual Study Completion Date : December 2017

Arm Intervention/treatment
Experimental: CLG561
CLG561, one IVT injection every 28 days for a total of 12 injections
Drug: CLG561
Experimental: CLG561+LFG316
CLG561+LFG316, 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 ]
  2. Number of subjects experiencing a non-serious adverse event [ Time Frame: Up to Day 421 ]
  3. Change in GA lesion size from baseline to Day 337 as measured by fundus autoflorescence (FAF) [ Time Frame: Baseline (Day 0), Day 337 ]

Secondary Outcome Measures :
  1. Frequency of serum total CLG561 concentrations below the lower limit of quantification (LLOQ) [ Time Frame: Up to Day 421 ]
  2. Frequency of subjects with anti-CLG561 and anti-LFG316 antibodies [ Time Frame: Up to Day 421 ]
  3. Percent change from baseline in serum total properdin and total C5 [ Time Frame: Up to Day 421 ]
  4. Percent change from baseline in serum complement activity [ Time Frame: Up to Day 421 ]
  5. Change in GA lesion size from baseline to Day 85, 169, 253, and 421 as measured by FAF in the study eye [ Time Frame: Baseline, up to Day 421 ]
  6. Change in Best Corrected Visual Acuity (BCVA)/low luminance visual acuity/low luminance visual acuity deficit from baseline by visit up to Day 337 as measured by early treatment diabetic retinopathy study (ETDRS) in the study eye [ Time Frame: Baseline (Day 0), up to Day 337 ]
    This outcome measure is pre-specified for CLG561 and CLG561+LFG316 arms.

  7. Average change in BCVA/low luminance visual acuity/low luminance visual acuity deficit from baseline to the period Day 281 to Day 337 as measured by ETDRS in the study eye [ Time Frame: Baseline (Day 0), up to Day 337 ]
    This outcome measure is pre-specified for CLG561 and CLG561+LFG316 arms.

  8. Proportion of subjects with letter change in BCVA from baseline up to Day 337 as measured by ETDRS in the study eye [ Time Frame: Baseline (Day 0), up to Day 337 ]
    This outcome measure is pre-specified for CLG561 and CLG561+LFG316 arms.



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.


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


Locations
United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Novartis Institutes for BioMedical Research
Investigators
Study Director: Sr Clinical Manager, Pharma, GCRA Alcon Research

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
Last Update Posted: December 7, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Atrophy
Geographic Atrophy
Pathological Conditions, Anatomical
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases