Overview

This trial is active, not recruiting.

Condition geographic atrophy
Treatments clg561, lfg316, sham injection
Phase phase 2
Sponsor Alcon Research
Collaborator Novartis Institutes for BioMedical Research
Start date September 2015
End date December 2017
Trial size 114 participants
Trial identifier NCT02515942, CCLG561X2201, CLG561-2201

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
CLG561, one IVT injection every 28 days for a total of 12 injections
clg561
(Experimental)
CLG561+LFG316, one IVT injection every 28 days for a total of 12 injections
clg561
lfg316
(Sham Comparator)
One sham injection every 28 days for total of 12 sham injections
sham injection
Empty syringe (without a needle) placed against the eye

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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
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
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

Eligibility Criteria

Male or female participants at least 50 years old.

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.

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Alcon Research.