Phase 2 N=114 Randomized Single-blind Treatment

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

Geographic Atrophy

Bottom Line

View on ClinicalTrials.gov: NCT02515942 ↗

Enrolled (actual)

114

Serious AEs

14.9%

Results posted

Dec 2018

Primary outcome: Primary: Number of Subjects With a Serious Adverse Event That, in the Opinion of the Investigator, is Related to the Study Drug — 0; 0; 0 subjects

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: CLG561 (Drug); LFG316 (Drug); Sham injection (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Alcon Research
Primary completion: Aug 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects With a Serious Adverse Event That, in the Opinion of the Investigator, is Related to the Study Drug	0; 0; 0	—
PRIMARY Mean Change From Baseline in Intraocular Pressure (IOP)	15.1; 14.5; 15.5; -0.2; 0.0; -0.7	—
PRIMARY Change in GA Lesion Size From Baseline to Day 337 as Measured by Fundus Autofluorescence (FAF)	1.53; 1.88; 1.82	0.0636
SECONDARY Change in GA Lesion Size From Baseline to Day 85, 169, and 253 as Measured by FAF	0.41; 0.41; 0.37; 0.69; 0.81; 0.82	0.5029
SECONDARY Mean Change in GA Lesion Size From Baseline to Day 421 as Measured by FAF	9.090; 9.070; 9.017; 2.056; 2.449; 2.395	—
SECONDARY Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS)	-0.93; 1.79; -1.44; 2.14; 2.46; 0.86	0.9243
SECONDARY Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS	-0.57; -0.72; -1.03; 0.99; 3.87; 1.39	0.4609
SECONDARY Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS	-0.43; 2.32; -0.15; 2.43; 1.27; 0.06	0.0913
SECONDARY Average Change in BCVA From Baseline to the Period Day 281 to Day 337 as Measured by ETDRS	3.0; 2.3; -0.3	—
SECONDARY Average Change in LLVA From Baseline to the Period Day 281 to Day 337 as Measured by ETDRS	3.6; 0.4; -2.2	—
SECONDARY Average LLVA Deficit (Letters) Change From Baseline at Day 281 to Day 337 as Measured by ETDRS	-0.6; 1.9; 1.9	—
SECONDARY Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS	2.9; 2.8; 0.0; 8.6; 5.6; 2.7	—
SECONDARY Total CLG561 Serum Concentrations up to Day 421	0; 0; 998; 475; 821; 417	—
SECONDARY Total LFG316 Serum Concentration up to Day 421	0; 338; 0	—
SECONDARY Percentage of Subjects With Anti-CLG561 Antibodies up to Day 421	0; 7.7	—
SECONDARY Percentage of Subjects With Anti-LFG316 Antibodies up to Day 421	—	—

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02515942). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.