Geographic AtrophyPhase 2NCT02515942

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

A Phase 2 study testing CLG561 and LFG316 in people with Geographic Atrophy, run by Alcon Research.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Geographic Atrophy
What is being tested?: CLG561 and LFG316
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 114 participants
Where: No sites listed yet
Study dates: 25 Sep 2015to 1 Dec 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Sign written informed consent form;
Geographic atrophy in both eyes;
Other protocol-specified inclusion criteria may apply.

Who cannot join

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.

About this study

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

Read the 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.

Conditions: Geographic Atrophy
Being tested: CLG561, LFG316, Sham injection
Keywords: Geographic atrophy (GA), Macular degeneration, Dry age-related macular degeneration (AMD), Intravitreal (IVT), Retinal diseases, Fundus auto fluorescence (FAF)
Medical subject headings: Geographic Atrophy, Macular Degeneration, Retinal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CLG561Drug
LFG316Drug
Sham injectionDrug
Empty syringe (without a needle) placed against the eye

Study groups in NCT02515942
Study group	Role	What they receive
CLG561	Experimental	CLG561 10 mg, one IVT injection every 28 days for a total of 12 injections Receives: Drug: CLG561
CLG561+LFG316	Experimental	CLG561 5mg + LFG316 5 mg, one IVT injection every 28 days for a total of 12 injections Receives: Drug: CLG561; Drug: LFG316
Sham Injection	Sham comparator	One sham injection every 28 days for total of 12 sham injections Receives: Drug: Sham injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: Baseline (Day 1), Day 85, Day 169, Day 253
Mean Change in GA Lesion Size From Baseline to Day 421 as Measured by 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. Day 421 measurements were only summarized descriptively and did not include any statistical modeling.
Measured: 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)
BCVA was assessed using ETDRS testing at 4 meters. Baseline is defined as the last measurement prior to first dose of treatment. BCVA change was defined as a change in letters read from the baseline assessment. A positive change value indicates improvement. One eye (study eye) contributed to the analysis.
Measured: 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
Low Luminance Visual Acuity (VA) was assessed using ETDRS testing at 4 meters with a neutral density filter to reduce chart luminance to 3 candelas/m2. Baseline is defined as the last measurement prior to first dose of treatment. BCVA change was defined as a change in letters read from the baseline assessment. A positive change value indicates improvement. One eye (study eye) contributed to the analysis.
Measured: 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
Low Luminance Visual Acuity (VA) was assessed using ETDRS testing at 4 meters with a neutral density filter to reduce chart luminance to 3 candelas/m2. A deficit in LLVA is defined as a loss in letters read from baseline. Baseline is defined as the last measurement prior to first dose of treatment. A negative change value indicates improvement (more letters read). One eye (study eye) contributed to the analysis.
Measured: 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
Average Change in BCVA From Baseline to the Period Day 281 to Day 337 as Measured by ETDRS
BCVA was assessed using ETDRS testing at 4 meters. Day 281, Day 309, and Day 337 were averaged and compared to baseline. BCVA change was defined as a change in letters read from the baseline assessment. A positive change value indicates improvement. One eye (study eye) contributed to the analysis. No statistical analysis was conducted.
Measured: Baseline (Day 1), Day 281, Day 309, Day 337
Average Change in LLVA From Baseline to the Period Day 281 to Day 337 as Measured by ETDRS
LLVA was assessed at 4 meters using a neutral density filter to reduce chart luminance to 3 candelas/m2. Baseline is defined as the last measurement prior to first dose of treatment. Day 281, Day 309, and Day 337 were averaged and compared to baseline. BCVA change was defined as a change in letters read from the baseline assessment. A positive change value indicates improvement. One eye (study eye) contributed to the analysis. No statistical analysis was conducted.
Measured: Baseline (Day 1), Day 281, Day 309, Day 337
Average LLVA Deficit (Letters) Change From Baseline at Day 281 to Day 337 as Measured by ETDRS
LLVA was assessed at 4 meters using a neutral density filter to reduce chart luminance to 3 candelas/m2. A deficit in LLVA is defined as a loss in letters read from baseline. Baseline is defined as the last measurement prior to first dose of treatment. Day 281, Day 309, and Day 337 were averaged and compared to baseline. A negative change value indicates improvement (more letters read). One eye (study eye) contributed to the analysis.
Measured: Baseline (Day 1), Day 281, Day 309, Day 337
Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS
BCVA was assessed using ETDRS testing at 4 meters. Baseline is defined as the last measurement prior to first dose of treatment. BCVA change was defined as a change in letters read from the baseline assessment and is reported categorically. One eye (study eye) contributed to the analysis. No statistical analysis was conducted.
Measured: 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
Total CLG561 Serum Concentrations up to Day 421
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method.
Measured: Baseline (Day 1), Day 2, Day 8, Day 15, Day 29, Day 85, Day 169, Day 253, Day 309, Day 337, Day 421
Total LFG316 Serum Concentration up to Day 421
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method.
Measured: Baseline (Day 1), Day 337, Day 421
Percentage of Subjects With Anti-CLG561 Antibodies up to Day 421
Samples were collected and assessed for anti-CLG561 antibodies.
Measured: Baseline (Day 1), up to Day 421
Percentage of Subjects With Anti-LFG316 Antibodies up to Day 421
Samples were collected and assessed for anti-LFG316 antibodies.
Measured: Baseline (Day 1), up to Day 421

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Sep 20151 Dec 2017

First posted5 Aug 2015 (estimated)
Study start25 Sep 2015
Primary completion14 Aug 2017
Study completion1 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Geographic AtrophyStudies of the same condition, open and under way.
More trials run by Alcon ResearchThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 114 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02515942
Sponsor's protocol ID: CLG561-2201
Other IDs: CCLG561X2201
Status last verified: May 2019
First submitted: 3 Aug 2015
Last updated: 30 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

Publications

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.
PubMed 37314061

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingPhase 1/2
Phase 1/2 Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
Age-Related Macular Degeneration, Geographic Atrophy
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingPhase 3
A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy
Age-related Macular Degeneration (AMD), Geographic Atrophy (GA)
RecruitingPhase 1
Phase 1 Study of C.001 in Retinal Degeneration
Geographic Atrophy, Stargardt Disease
RecruitingPhase 2/3
A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
Geographic Atrophy, Macular Degeneration

All Geographic Atrophy trials

Study at a glance

From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02515942
Acronym / sponsor ID: CLG561-2201
Conditions: Geographic Atrophy
Keywords: Geographic atrophy (GA), Macular degeneration, Dry age-related macular degeneration (AMD), Intravitreal (IVT), Retinal diseases, Fundus auto fluorescence (FAF)
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 114 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Collaborators: Novartis Institutes for BioMedical Research
Study start: 25 Sep 2015 (actual)
Primary completion: 14 Aug 2017 (actual)
Study completion: 1 Dec 2017 (actual)
First posted: 5 Aug 2015 (estimated)
Results: Posted 19 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
CLG561	Experimental	Drug: CLG561CLG561 10 mg, one IVT injection every 28 days for a total of 12 injections
CLG561+LFG316	Experimental	Drug: CLG561, Drug: LFG316CLG561 5mg + LFG316 5 mg, one IVT injection every 28 days for a total of 12 injections
Sham Injection	Sham comparator	Drug: Sham injectionOne sham injection every 28 days for total of 12 sham injections

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Sign written informed consent form;
Geographic atrophy in both eyes;
Other protocol-specified inclusion criteria may apply.

Key exclusion criteria (7 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CLG561	Drug	CLG561, CLG561+LFG316
LFG316	Drug	CLG561+LFG316
Sham injectionEmpty syringe (without a needle) placed against the eye	Drug	Sham Injection

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
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.
Mean Change From Baseline in Intraocular Pressure (IOP)
Time frame: 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
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.
Change in GA Lesion Size From Baseline to Day 337 as Measured by Fundus Autofluorescence (FAF)
Time frame: Baseline (Day 1), Day 337
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.

13 secondary outcomes

Change in GA Lesion Size From Baseline to Day 85, 169, and 253 as Measured by FAF
Time frame: Baseline (Day 1), Day 85, Day 169, Day 253
Mean Change in GA Lesion Size From Baseline to Day 421 as Measured by FAF
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Average Change in BCVA From Baseline to the Period Day 281 to Day 337 as Measured by ETDRS
Time frame: Baseline (Day 1), Day 281, Day 309, Day 337
Average Change in LLVA From Baseline to the Period Day 281 to Day 337 as Measured by ETDRS
Time frame: Baseline (Day 1), Day 281, Day 309, Day 337
Average LLVA Deficit (Letters) Change From Baseline at Day 281 to Day 337 as Measured by ETDRS
Time frame: Baseline (Day 1), Day 281, Day 309, Day 337
Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS
Time frame: 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
Total CLG561 Serum Concentrations up to Day 421
Time frame: Baseline (Day 1), Day 2, Day 8, Day 15, Day 29, Day 85, Day 169, Day 253, Day 309, Day 337, Day 421
Total LFG316 Serum Concentration up to Day 421
Time frame: Baseline (Day 1), Day 337, Day 421
Percentage of Subjects With Anti-CLG561 Antibodies up to Day 421
Time frame: Baseline (Day 1), up to Day 421
Percentage of Subjects With Anti-LFG316 Antibodies up to Day 421
Time frame: Baseline (Day 1), up to Day 421

Results and safety

Results posted to the registry on 19 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CLG561	36	29
CLG561+LFG316	39	36
Sham Injection	39	35

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. Unit: subjects

Measure	CLG561 n = 36	CLG561+LFG316 n = 39	Sham Injection n = 39
Value	0	0	0

Population analysed: Safety Analysis Set

Primary outcome: Mean Change From Baseline in Intraocular Pressure (IOP)

Time frame: 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. Mean (Standard Deviation). Unit: mmHg

Measure	CLG561 n = 36	CLG561+LFG316 n = 39	Sham Injection n = 39
Baseline (BL) (Day 1)	15.1 (3.58)	14.5 (3.42)	15.5 (3.54)
Change from BL at Day 29	-0.2 (2.57)	0.0 (2.95)	-0.7 (3.74)
Change from BL at Day 57	-0.2 (3.46)	-0.4 (2.70)	-0.1 (3.06)
Change from BL at Day 85	-0.1 (2.80)	-0.1 (3.02)	0.2 (2.86)
Change from BL at Day 113	0.2 (3.84)	0.4 (3.31)	-0.7 (2.69)
Change from BL at Day 141	0.4 (2.93)	0.1 (3.82)	-0.6 (3.09)
Change from BL at Day 169	0.4 (4.35)	-0.1 (3.33)	-0.6 (3.75)
Change from BL at Day 197	-0.4 (3.88)	-0.0 (3.74)	-0.2 (3.13)

Population analysed: Safety Analysis Set. At each time point, only subjects with a value at both baseline and that time point are included.

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

Time frame: Baseline (Day 1), Day 337. Least squares mean (80% Confidence Interval). Unit: square millimeters (mm2)

Measure	CLG561 n = 29	CLG561+LFG316 n = 34	Sham Injection n = 33
Value	1.53 (1.31 to 1.74)	1.88 (1.68 to 2.08)	1.82 (1.61 to 2.03)

CLG561 vs CLG561+LFG316: Treatment Effect: -0.35 (80% CI -0.64 to -0.06), p = 0.0636, ANCOVA
CLG561 vs Sham Injection: Treatment Effect: -0.29 (80% CI -0.59 to 0.00), p = 0.1019, ANCOVA
CLG561+LFG316 vs Sham Injection: Treatment Effect: 0.06 (80% CI -0.24 to 0.35), p = 0.5987, ANCOVA

Population analysed: PPS. Only subjects with a value at both baseline and that time point are included.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 through study completion, an average of 336 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CLG561	5 of 36 (13.9%)	27 of 36 (75%)	1 of 36
CLG561+LFG316	5 of 39 (12.8%)	31 of 39 (79.5%)	0 of 39
Sham Injection	7 of 39 (17.9%)	29 of 39 (74.4%)	1 of 39

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37314061Tzoumas 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.
Individual participant dataSharing planned: Undecided. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

Related trials for Geographic Atrophy

Active, not recruitingPhase 1/2
Phase 1/2 Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
Age-Related Macular Degeneration, Geographic Atrophy
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingPhase 3
A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy
Age-related Macular Degeneration (AMD), Geographic Atrophy (GA)
RecruitingPhase 1
Phase 1 Study of C.001 in Retinal Degeneration
Geographic Atrophy, Stargardt Disease
RecruitingPhase 2/3
A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
Geographic Atrophy, Macular Degeneration

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sr Clinical Manager, Pharma, GCRA study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CLG561 and LFG316 in people with Geographic Atrophy, run by Alcon Research.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02515942, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2019.