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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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 Geograp

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.

Detailed Summary: 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.
Sponsor: Alcon Research

Current Primary Outcome:

  • 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 ]
  • Number of subjects experiencing a non-serious adverse event [ Time Frame: Up to Day 421 ]
  • Change in GA lesion size from baseline to Day 337 as measured by fundus autoflorescence (FAF) [ Time Frame: Baseline (Day 0), Day 337 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Frequency of serum total CLG561 concentrations below the lower limit of quantification (LLOQ) [ Time Frame: Up to Day 421 ]
  • Frequency of subjects with anti-CLG561 and anti-LFG316 antibodies [ Time Frame: Up to Day 421 ]
  • Percent change from baseline in serum total properdin and total C5 [ Time Frame: Up to Day 421 ]
  • Percent change from baseline in serum complement activity [ Time Frame: Up to Day 421 ]
  • 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 ]
  • 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.
  • 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.
  • 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.


Original Secondary Outcome:

  • Frequency of serum total CLG561 concentrations below the lower limit of quantification (LLOQ) [ Time Frame: Up to Day 421 ]
  • Frequency of subjects with anti-CLG561 and anti-LFG316 antibodies [ Time Frame: Up to Day 421 ]
  • Percent change from baseline in serum total properdin and total C5 [ Time Frame: Up to Day 421 ]
  • Percent change from baseline in serum complement activity [ Time Frame: Up to Day 421 ]
  • Change in GA lesion size from baseline to Day 85, 169, 253, and 421 as measured by FAF [ Time Frame: Baseline, up to Day 421 ]
  • Change in GA lesion size from baseline to Days 169 and 337 as measured in the study eye and the fellow eye by FAF [ Time Frame: Baseline, up to Day 337 ]
    This outcome measure is pre-specified for CLG561 and CLG561+LFG316 arms.
  • 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) [ Time Frame: Baseline (Day 0), up to Day 337 ]
  • Change in BCVA/low luminance visual acuity/low luminance visual acuity deficit from baseline by visit up to Day 337 as measured in the study eye and the fellow eye by ETDRS [ Time Frame: Baseline (Day 0), up to Day 337 ]
    This outcome measure is pre-specified for CLG561 and CLG561+LFG316 arms.
  • Proportion of subjects with letter change in BCVA from baseline up to Day 337 as measured by ETDRS [ Time Frame: Baseline (Day 0), up to Day 337 ]
  • Proportion of subjects with letter change in BCVA from baseline up to Day 337 as measured in the study eye and fellow eye by ETDRS [ Time Frame: Baseline (Day 0), up to Day 337 ]
    This outcome measure is pre-specified for CLG561 and CLG561+LFG316 arms.


Information By: Alcon Research

Dates:
Date Received: August 3, 2015
Date Started: September 25, 2015
Date Completion: November 30, 2017
Last Updated: April 17, 2017
Last Verified: April 2017