NCT02515942

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 5, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

September 25, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
1 year until next milestone

Results Posted

Study results publicly available

December 19, 2018

Completed
Last Updated

May 30, 2019

Status Verified

May 1, 2019

Enrollment Period

1.9 years

First QC Date

August 3, 2015

Results QC Date

November 12, 2018

Last Update Submit

May 17, 2019

Conditions

Geographic Atrophy

Keywords

Geographic atrophy (GA)Macular degenerationDry age-related macular degeneration (AMD)Intravitreal (IVT)Retinal diseasesFundus auto fluorescence (FAF)

Outcome Measures

Primary Outcomes (3)

  • Number of Subjects With a Serious Adverse Event That, in the Opinion of the Investigator, is Related to the Study Drug

    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.

    Up to Day 421

  • Mean Change From Baseline in Intraocular Pressure (IOP)

    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.

    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

  • Change in GA Lesion Size From Baseline to Day 337 as Measured by Fundus Autofluorescence (FAF)

    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.

    Baseline (Day 1), Day 337

Secondary Outcomes (13)

  • Change in GA Lesion Size From Baseline to Day 85, 169, and 253 as Measured by FAF

    Baseline (Day 1), Day 85, Day 169, Day 253

  • Mean Change in GA Lesion Size From Baseline to Day 421 as Measured by FAF

    Baseline (Day 1), Day 421

  • Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS)

    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

  • Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS

    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

  • Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS

    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

  • +8 more secondary outcomes

Study Arms (3)

CLG561

EXPERIMENTAL

CLG561 10 mg, one IVT injection every 28 days for a total of 12 injections

Drug: CLG561

CLG561+LFG316

EXPERIMENTAL

CLG561 5mg + LFG316 5 mg, one IVT injection every 28 days for a total of 12 injections

Drug: CLG561Drug: LFG316

Sham Injection

SHAM COMPARATOR

One sham injection every 28 days for total of 12 sham injections

Drug: Sham injection

Interventions

CLG561DRUG
CLG561CLG561+LFG316
LFG316DRUG
CLG561+LFG316
Sham injectionDRUG

Empty syringe (without a needle) placed against the eye

Sham Injection

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sign written informed consent form;
  • Geographic atrophy in both eyes;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Tzoumas N, Riding G, Williams MA, Steel DH. Complement inhibitors for age-related macular degeneration. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD009300. doi: 10.1002/14651858.CD009300.pub3.

    PMID: 37314061DERIVED

MeSH Terms

Conditions

Geographic AtrophyMacular DegenerationRetinal Diseases

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Retinal DegenerationEye Diseases

Results Point of Contact

Title
WW Brand Medical Director Ophtha, GMA Ophthalmics
Organization
Alcon, A Novartis Division
alcon.medinfo@alcon.com
1-888-451-3937

Study Officials

  • Sr Clinical Manager, Pharma, GCRA

    Alcon Research

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2015

First Posted

August 5, 2015

Study Start

September 25, 2015

Primary Completion

August 14, 2017

Study Completion

December 1, 2017

Last Updated

May 30, 2019

Results First Posted

December 19, 2018

Record last verified: 2019-05