Age-related Macular DegenerationPhase 1NCT01835015

Pharmacokinetics of CLG561 in Patients With Advanced Age-Related Macular Degeneration

A Phase 1 study testing CLG561 in people with Age-related Macular Degeneration, 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, tolerability, and serum pharmacokinetics of CLG561 in subjects with advanced age-related macular degeneration (AMD). Read more about this study

Who is it for?: Ages 55 to 90 years
Conditions the study is for: Age-related Macular Degeneration
What is being tested?: CLG561
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: No sites listed yet
Study dates: May 2013to Nov 2014
Phase: Phase 1
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 55 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of age-related macular degeneration in study eye, as specified in protocol.
Poor visual acuity in study eye, as specified in protocol.
Willing to receive meningitis and pneumonia vaccinations at least 2 weeks prior to study treatment.
Females must be post-menopausal and/or surgically sterile.
Other protocol-defined inclusion criteria may apply.

Who cannot join

Treatments to the study eye within 28 days prior to study treatment, as specified in protocol.
Any disease or medication expected to cause systemic or ocular immunosuppression.
Participation in another interventional clinical study or use of any experimental treatment for AMD within 12 weeks prior to study treatment.
Other protocol-defined exclusion criteria may apply.

About this study

Official title: A Multi-Center, Open-Label, Single Ascending Dose Study To Assess the Safety, Tolerability, and Serum Pharmacokinetics of Intravitreal CLG561 in Subjects With Advanced Age-Related Macular Degeneration

The purpose of this study is to evaluate the safety, tolerability, and serum pharmacokinetics of CLG561 in subjects with advanced age-related macular degeneration (AMD).

Read the detailed description

Subjects were divided into 5 cohorts, with the subjects in each cohort being administered a single IVT dose of CLG561 in 1 of 5 concentration levels A-E, where A=lowest and E=highest. All subjects received active CLG561. Progress from one cohort to the next was time-lagged to allow for safety review. Dosing was also time-lagged within each cohort. Only one eye (designated as the study eye) was dosed per subject. Post-dose safety assessments and ocular examination occurred immediately after the IVT injection and continued throughout the outpatient visits at pre-determined timepoints. Collection of post-injection blood samples began after the IVT injection at pre-determined timepoints. Subjects were followed for up to 84 days.

Conditions: Age-related Macular Degeneration
Being tested: CLG561
Keywords: First in human, Safety, Tolerability, Serum PK, Intravitreal (IVT), Age-related macular degeneration, AMD, Geographic Atrophy, Choroidal neovascularization
Medical subject headings: Macular Degeneration, Geographic Atrophy, Choroidal Neovascularization

What participants receive

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

CLG561Drug
Administered by intravitreal injection, Day 1

Study groups in NCT01835015
Study group	Role	What they receive
CLG561, Concentration Level A	Experimental	Single 50 μL intravitreal injection of CLG561, Dose Level A Receives: Drug: CLG561
CLG561, Concentration Level B	Experimental	Single 50 μL intravitreal injection of CLG561, Dose Level B Receives: Drug: CLG561
CLG561, Concentration Level C	Experimental	Single 50 μL intravitreal injection of CLG561, Dose Level C Receives: Drug: CLG561
CLG561, Concentration Level D	Experimental	Single 50 μL intravitreal injection of CLG561, Dose Level D Receives: Drug: CLG561
CLG561, Concentration Level E	Experimental	Single 100 μL intravitreal injection of CLG561, Dose Level E Receives: Drug: CLG561

What is being measured

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

Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) by Visit - Study Eye
BCVA (with spectacles or other visual corrective devices) using Early Treatment Diabetic Retinopathy Study (ETDRS) testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.
Measured: Baseline, Day 2, Day 4, Day 15, Day 29, Day 57, Day 85
Mean Intra-Ocular Pressure (IOP) by Visit - Study Eye
IOP was measured by Goldmann applanation tonometry or tonopen, at the discretion of the Investigator, and reported in mmHg (millimeters of mercury). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis.
Measured: Baseline, Day 1, Day 2, Day 4, Day 15, Day 29, Day 57, Day 85
Number of Subjects With Change From Normal to Abnormal in Fundus Examination at Any Post-Therapy Visit as Compared to Baseline Assessment
A dilated fundus examination was performed to evaluate the health of the retina, macula, choroid, and optic nerve. Subjects having a normal baseline evaluation were examined at subsequent visits, and any change from normal to abnormal was recorded. Criteria for reclassifying from normal to abnormal were left to the opinion of the investigators. One eye (study eye) contributed to the analysis. None of the abnormalities were deemed related to the study medication.
Measured: Baseline, Day 2, Day 4, Day 8, Day 15, Day 29, Day 57, Day 85
Number of Subjects With a Change From Normal to Abnormal in Ocular Signs at Any Post-Therapy Visit as Compared to Baseline Assessment
A slit-lamp biomicroscopy examination was performed to evaluate the anterior segment of the eye. Subjects having a normal baseline evaluation were examined at subsequent visits, and any change from normal to abnormal was recorded. Criteria for reclassifying from normal to abnormal were left to the opinion of the investigators. One eye (study eye) contributed to the analysis. None of the abnormalities were deemed related to the study medication.
Measured: Baseline, Day 2, Day 4, Day 8, Day 15, Day 29, Day 57, Day 85

Secondary outcomes (9)

Area Under the Serum Concentration-time Curve (AUC) From Time Zero to All [AUC(0-all)]
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.
Measured: Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85
Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-last)]
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental PK method.
Measured: Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85
Time to Reach the Maximum Serum Concentration After Drug Administration (Tmax)
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental PK method.
Measured: Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85
Dose Normalized Observed Maximum Serum Concentration Following Drug Administration (Cmax/D)
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental PK method.
Measured: Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85
Dose-normalized Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-last)/D]
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental PK method.
Measured: Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85
Area Under the Serum Concentration-time Curve From Time Zero to Time "t" Where t is a Defined Time Point After Administration [AUC(0-t)]
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method.
Measured: Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85
Terminal Elimination Half-life (T½)
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method.
Measured: Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85
The Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration (Vz/F)
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method.
Measured: Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85
Apparent Systemic (or Total Body) Clearance From Serum Following Extravascular Administration (CL/F)
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method.
Measured: Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85

Timeline

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

May 2013Nov 2014

First posted18 Apr 2013 (estimated)
Study startMay 2013
Primary completionNov 2014
Study completionNov 2014

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.
Other trials for Age-related Macular DegenerationStudies 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 1
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01835015
Sponsor's protocol ID: C-12-074
Status last verified: Feb 2016
First submitted: 16 Apr 2013
Last updated: 25 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

RecruitingPhase 3
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Neovascular Age-related Macular Degeneration
RecruitingObservational study
Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
Age-related Macular Degeneration (AMD)
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingObservational study
Retinal Pigment Epithelium Safety Study For Patients In B4711001
Age Related Macular Degeneration
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder

Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Open-Label, Single Ascending Dose Study To Assess the Safety, Tolerability, and Serum Pharmacokinetics of Intravitreal CLG561 in Subjects With Advanced Age-Related Macular Degeneration
ClinicalTrials.gov ID: NCT01835015
Acronym / sponsor ID: C-12-074
Conditions: Age-related Macular Degeneration
Keywords: First in human, Safety, Tolerability, Serum PK, Intravitreal (IVT), Age-related macular degeneration, AMD, Geographic Atrophy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: May 2013
Primary completion: Nov 2014 (actual)
Study completion: Nov 2014 (actual)
First posted: 18 Apr 2013 (estimated)
Results: Posted 25 Mar 2016

Clinical summary

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

The purpose of this study is to evaluate the safety, tolerability, and serum pharmacokinetics of CLG561 in subjects with advanced age-related macular degeneration (AMD).

Detailed description

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
CLG561, Concentration Level A	Experimental	Drug: CLG561Single 50 μL intravitreal injection of CLG561, Dose Level A
CLG561, Concentration Level B	Experimental	Drug: CLG561Single 50 μL intravitreal injection of CLG561, Dose Level B
CLG561, Concentration Level C	Experimental	Drug: CLG561Single 50 μL intravitreal injection of CLG561, Dose Level C
CLG561, Concentration Level D	Experimental	Drug: CLG561Single 50 μL intravitreal injection of CLG561, Dose Level D
CLG561, Concentration Level E	Experimental	Drug: CLG561Single 100 μL intravitreal injection of CLG561, Dose Level E

Who may qualify

Ages: 55 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Diagnosis of age-related macular degeneration in study eye, as specified in protocol.
Poor visual acuity in study eye, as specified in protocol.
Willing to receive meningitis and pneumonia vaccinations at least 2 weeks prior to study treatment.
Females must be post-menopausal and/or surgically sterile.
Other protocol-defined inclusion criteria may apply.

Key exclusion criteria (4 listed)

Treatments to the study eye within 28 days prior to study treatment, as specified in protocol.
Any disease or medication expected to cause systemic or ocular immunosuppression.
Participation in another interventional clinical study or use of any experimental treatment for AMD within 12 weeks prior to study treatment.
Other protocol-defined exclusion criteria may apply.

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
CLG561Administered by intravitreal injection, Day 1	Drug	CLG561, Concentration Level A, CLG561, Concentration Level B, CLG561, Concentration Level C, CLG561, Concentration Level D, CLG561, Concentration Level E

Primary outcome

Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) by Visit - Study Eye
Time frame: Baseline, Day 2, Day 4, Day 15, Day 29, Day 57, Day 85
BCVA (with spectacles or other visual corrective devices) using Early Treatment Diabetic Retinopathy Study (ETDRS) testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.
Mean Intra-Ocular Pressure (IOP) by Visit - Study Eye
Time frame: Baseline, Day 1, Day 2, Day 4, Day 15, Day 29, Day 57, Day 85
IOP was measured by Goldmann applanation tonometry or tonopen, at the discretion of the Investigator, and reported in mmHg (millimeters of mercury). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis.
Number of Subjects With Change From Normal to Abnormal in Fundus Examination at Any Post-Therapy Visit as Compared to Baseline Assessment
Time frame: Baseline, Day 2, Day 4, Day 8, Day 15, Day 29, Day 57, Day 85
A dilated fundus examination was performed to evaluate the health of the retina, macula, choroid, and optic nerve. Subjects having a normal baseline evaluation were examined at subsequent visits, and any change from normal to abnormal was recorded. Criteria for reclassifying from normal to abnormal were left to the opinion of the investigators. One eye (study eye) contributed to the analysis. None of the abnormalities were deemed related to the study medication.
Number of Subjects With a Change From Normal to Abnormal in Ocular Signs at Any Post-Therapy Visit as Compared to Baseline Assessment
Time frame: Baseline, Day 2, Day 4, Day 8, Day 15, Day 29, Day 57, Day 85
A slit-lamp biomicroscopy examination was performed to evaluate the anterior segment of the eye. Subjects having a normal baseline evaluation were examined at subsequent visits, and any change from normal to abnormal was recorded. Criteria for reclassifying from normal to abnormal were left to the opinion of the investigators. One eye (study eye) contributed to the analysis. None of the abnormalities were deemed related to the study medication.

9 secondary outcomes

Area Under the Serum Concentration-time Curve (AUC) From Time Zero to All [AUC(0-all)]
Time frame: Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85
Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-last)]
Time frame: Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85
Time to Reach the Maximum Serum Concentration After Drug Administration (Tmax)
Time frame: Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85
Dose Normalized Observed Maximum Serum Concentration Following Drug Administration (Cmax/D)
Time frame: Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85
Dose-normalized Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-last)/D]
Time frame: Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85
Area Under the Serum Concentration-time Curve From Time Zero to Time "t" Where t is a Defined Time Point After Administration [AUC(0-t)]
Time frame: Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85
Terminal Elimination Half-life (T½)
Time frame: Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85
The Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration (Vz/F)
Time frame: Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85
Apparent Systemic (or Total Body) Clearance From Serum Following Extravascular Administration (CL/F)
Time frame: Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85

Results and safety

Results posted to the registry on 25 Mar 2016, 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, Level A	6	6
CLG561, Level B	6	6
CLG561, Level C	7	6
CLG561, Level D	6	6
CLG561, Level E	6	6

Primary outcome: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) by Visit - Study Eye

Time frame: Baseline, Day 2, Day 4, Day 15, Day 29, Day 57, Day 85. Mean (Standard Deviation). Unit: letters

Measure	CLG561, Level A n = 6	CLG561, Level B n = 6	CLG561, Level C n = 7	CLG561, Level D n = 6	CLG561, Level E n = 6
Baseline, n=6,6,7,6,6	23.7 (16.55)	25.7 (15.20)	27.6 (17.67)	41.5 (20.42)	38.0 (11.75)
Change from Baseline, Day 2, n=6,6,7,6,6	0.7 (8.24)	2.5 (5.24)	1.1 (3.02)	0.0 (5.73)	-1.0 (10.02)
Change from Baseline, Day 4, n=6,6,7,6,6	3.5 (8.53)	4.8 (4.67)	1.7 (3.04)	1.8 (5.19)	3.3 (7.87)
Change from Baseline, Day 15, n=6,6,6,6,6	2.7 (7.99)	3.7 (4.50)	2.0 (4.73)	3.5 (8.26)	5.2 (8.06)
Change from Baseline, Day 29, n=6,5,6,6,6	2.2 (5.85)	4.8 (5.02)	1.3 (5.28)	2.0 (6.84)	1.5 (4.51)
Change from Baseline, Day 57, n=6,5,6,6,6	4.7 (11.09)	2.0 (3.24)	2.5 (5.75)	4.2 (11.09)	2.3 (2.94)
Change from Baseline, Day 85, n=6,6,6,6,6	3.8 (9.43)	3.0 (4.86)	2.2 (5.12)	2.2 (5.12)	3.2 (5.12)

Population analysed: This analysis population includes all enrolled subjects who received investigational product. Here, "n" is the number of subjects with non-missing values at the specific time point for each arm group, respectively.

Primary outcome: Mean Intra-Ocular Pressure (IOP) by Visit - Study Eye

Time frame: Baseline, Day 1, Day 2, Day 4, Day 15, Day 29, Day 57, Day 85. Mean (Standard Deviation). Unit: mmHg

Measure	CLG561, Level A n = 6	CLG561, Level B n = 6	CLG561, Level C n = 7	CLG561, Level D n = 6	CLG561, Level E n = 6
Baseline, n=6,6,7,6,6	14.7 (2.16)	14.3 (2.42)	15.7 (3.86)	15.2 (3.06)	16.5 (3.67)
Day 1, n=6,6,7,6,6	16.3 (3.72)	20.2 (8.01)	16.6 (6.24)	22.3 (3.50)	20.2 (3.97)
Day 2, n=6,6,7,6,6	16.0 (1.79)	14.5 (1.05)	14.3 (3.15)	14.0 (4.00)	15.0 (3.10)
Day 4, n=6,6,7,6,6	16.2 (2.32)	14.5 (3.99)	15.1 (4.74)	14.7 (4.23)	15.3 (3.93)
Day 15, n=6,6,6,6,6	14.0 (1.67)	15.5 (2.81)	16.2 (6.21)	16.2 (3.76)	16.5 (4.09)
Day 29, n=6,5,6,6,6	16.8 (3.19)	16.8 (4.60)	16.0 (4.94)	16.8 (4.26)	16.2 (4.67)
Day 57, n=6,5,6,6,6	17.7 (2.94)	15.6 (5.32)	16.3 (3.27)	16.3 (2.25)	15.8 (3.13)
Day 85, n=6,6,6,6,6	16.5 (2.07)	15.5 (5.24)	16.7 (4.27)	16.2 (4.07)	16.2 (4.26)

Primary outcome: Number of Subjects With Change From Normal to Abnormal in Fundus Examination at Any Post-Therapy Visit as Compared to Baseline Assessment

Time frame: Baseline, Day 2, Day 4, Day 8, Day 15, Day 29, Day 57, Day 85. Number. Unit: participants

Measure	CLG561, Level A n = 6	CLG561, Level B n = 6	CLG561, Level C n = 7	CLG561, Level D n = 6	CLG561, Level E n = 6
Retina: Baseline Normal	5	4	4	6	5
Retina: Change from Normal to Abnormal	1	0	0	0	1
Macula: Baseline Normal	6	6	6	6	6
Macula: Change from Normal to Abnormal	0	0	0	0	1
Choroid: Baseline Normal	6	6	6	6	6
Choroid: Change from Normal to Abnormal	0	0	0	0	0
Optic Nerve: Baseline Normal	6	3	5	6	5
Optic Nerve: Change from Normal to Abnormal	1	0	2	0	0

Population analysed: This analysis population includes all enrolled subjects who received investigational product.

Primary outcome: Number of Subjects With a Change From Normal to Abnormal in Ocular Signs at Any Post-Therapy Visit as Compared to Baseline Assessment

Time frame: Baseline, Day 2, Day 4, Day 8, Day 15, Day 29, Day 57, Day 85. Number. Unit: participants

Measure	CLG561, Level A n = 6	CLG561, Level B n = 6	CLG561, Level C n = 7	CLG561, Level D n = 6	CLG561, Level E n = 6
Lids/Lashes: Baseline Normal	5	4	5	6	6
Lids/Lashes: Change from Normal to Abnormal	0	1	1	0	1
Conjunctiva: Baseline Normal	5	4	6	5	5
Conjunctiva: Change from Normal to Abnormal	2	1	4	0	2
Cornea: Baseline Normal	6	5	6	6	5
Cornea: Change from Normal to Abnormal	0	0	2	0	1
Iris: Baseline Normal	6	6	6	6	6
Iris: Change from Normal to Abnormal	0	0	0	0	0

Population analysed: This analysis population includes all enrolled subjects who received investigational product.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CLG561, Level A	1 of 6 (16.7%)	5 of 6 (83.3%)	Not reported
CLG561, Level B	0 of 6 (0%)	3 of 6 (50%)	Not reported
CLG561, Level C	1 of 7 (14.3%)	6 of 7 (85.7%)	Not reported
CLG561, Level D	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
CLG561, Level E	0 of 6 (0%)	3 of 6 (50%)	Not reported
Pretreatment	0 of 50 (0%)	0 of 50 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Head of Clinical Sciences, CA CSI NS/Opth study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CLG561 in people with Age-related Macular Degeneration, 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 5 inclusion and 4 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 25 Mar 2016. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 25 Mar 2016). 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?

Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) by Visit - Study Eye (time frame: Baseline, Day 2, Day 4, Day 15, Day 29, Day 57, Day 85). The study lists 4 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 NCT01835015.

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 25 Mar 2016.