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CompletedNCT01835015Updated Mar 25, 2016Results posted

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

A Phase 1 interventional study of CLG561 in Age-related Macular Degeneration, sponsored by Alcon Research. Completed. Open to participants aged 55 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-03-25.

Sponsored by Alcon Research (part of Alcon) · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
55 Years to 90 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Age-related Macular Degeneration

Keywords

  • First in human
  • Safety
  • Tolerability
  • Serum PK
  • Intravitreal (IVT)
  • Age-related macular degeneration
  • AMD
  • Geographic Atrophy
  • Choroidal neovascularization
03

In context

Macular Degeneration

1,490 studies on the registry are indexed under Macular Degeneration; 208 are open to participants now.

This study's enrollment of 50 is close to the median of 50 across 993 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 100 (90%) have results posted.

Browse Alcon Research studies →All Alcon studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    CLG561, Concentration Level A

    Single 50 μL intravitreal injection of CLG561, Dose Level A

    Drug: CLG561

  • Experimental
    CLG561, Concentration Level B

    Single 50 μL intravitreal injection of CLG561, Dose Level B

    Drug: CLG561

  • Experimental
    CLG561, Concentration Level C

    Single 50 μL intravitreal injection of CLG561, Dose Level C

    Drug: CLG561

  • Experimental
    CLG561, Concentration Level D

    Single 50 μL intravitreal injection of CLG561, Dose Level D

    Drug: CLG561

  • Experimental
    CLG561, Concentration Level E

    Single 100 μL intravitreal injection of CLG561, Dose Level E

    Drug: CLG561

Interventions

  • DrugCLG561

    Administered by intravitreal injection, Day 1

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, Day 2, Day 4, Day 15, Day 29, Day 57, Day 85

  2. 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.

    Time frame: Baseline, Day 1, Day 2, Day 4, Day 15, Day 29, Day 57, Day 85

  3. 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.

    Time frame: Baseline, Day 2, Day 4, Day 8, Day 15, Day 29, Day 57, Day 85

  4. 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.

    Time frame: Baseline, Day 2, Day 4, Day 8, Day 15, Day 29, Day 57, Day 85

Secondary outcomes

  1. 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.

    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

  2. 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.

    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

  3. 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.

    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

  4. 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.

    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

  5. 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.

    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

  6. 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.

    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

  7. Terminal Elimination Half-life (T½)

    Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method.

    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

  8. 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.

    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

  9. 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.

    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

07

Results

Posted Mar 25, 2016

Participant flow

Subjects were recruited from 4 investigational centers located in the US.

Participant flow — Overall Study
MilestoneCLG561, Level ACLG561, Level BCLG561, Level CCLG561, Level DCLG561, Level E
Started66766
Completed66666
Not completed00100
Withdrew: Adverse event00100

Outcome measures

PrimaryMean 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.

Time frame:
Baseline, Day 2, Day 4, Day 15, Day 29, Day 57, Day 85
Reported as:
Mean · letters
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) by Visit - Study Eye
lettersCLG561, Level ACLG561, Level BCLG561, Level CCLG561, Level DCLG561, Level E
Baseline, n=6,6,7,6,623.7 ± 16.5525.7 ± 15.2027.6 ± 17.6741.5 ± 20.4238.0 ± 11.75
Change from Baseline, Day 2, n=6,6,7,6,60.7 ± 8.242.5 ± 5.241.1 ± 3.020.0 ± 5.73-1.0 ± 10.02
Change from Baseline, Day 4, n=6,6,7,6,63.5 ± 8.534.8 ± 4.671.7 ± 3.041.8 ± 5.193.3 ± 7.87
Change from Baseline, Day 15, n=6,6,6,6,62.7 ± 7.993.7 ± 4.502.0 ± 4.733.5 ± 8.265.2 ± 8.06
Change from Baseline, Day 29, n=6,5,6,6,62.2 ± 5.854.8 ± 5.021.3 ± 5.282.0 ± 6.841.5 ± 4.51
Change from Baseline, Day 57, n=6,5,6,6,64.7 ± 11.092.0 ± 3.242.5 ± 5.754.2 ± 11.092.3 ± 2.94
Change from Baseline, Day 85, n=6,6,6,6,63.8 ± 9.433.0 ± 4.862.2 ± 5.122.2 ± 5.123.2 ± 5.12
PrimaryMean 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.

Time frame:
Baseline, Day 1, Day 2, Day 4, Day 15, Day 29, Day 57, Day 85
Reported as:
Mean · mmHg
Mean Intra-Ocular Pressure (IOP) by Visit - Study Eye
mmHgCLG561, Level ACLG561, Level BCLG561, Level CCLG561, Level DCLG561, Level E
Baseline, n=6,6,7,6,614.7 ± 2.1614.3 ± 2.4215.7 ± 3.8615.2 ± 3.0616.5 ± 3.67
Day 1, n=6,6,7,6,616.3 ± 3.7220.2 ± 8.0116.6 ± 6.2422.3 ± 3.5020.2 ± 3.97
Day 2, n=6,6,7,6,616.0 ± 1.7914.5 ± 1.0514.3 ± 3.1514.0 ± 4.0015.0 ± 3.10
Day 4, n=6,6,7,6,616.2 ± 2.3214.5 ± 3.9915.1 ± 4.7414.7 ± 4.2315.3 ± 3.93
Day 15, n=6,6,6,6,614.0 ± 1.6715.5 ± 2.8116.2 ± 6.2116.2 ± 3.7616.5 ± 4.09
Day 29, n=6,5,6,6,616.8 ± 3.1916.8 ± 4.6016.0 ± 4.9416.8 ± 4.2616.2 ± 4.67
Day 57, n=6,5,6,6,617.7 ± 2.9415.6 ± 5.3216.3 ± 3.2716.3 ± 2.2515.8 ± 3.13
Day 85, n=6,6,6,6,616.5 ± 2.0715.5 ± 5.2416.7 ± 4.2716.2 ± 4.0716.2 ± 4.26
PrimaryNumber 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.

Time frame:
Baseline, Day 2, Day 4, Day 8, Day 15, Day 29, Day 57, Day 85
Reported as:
Number · participants
Number of Subjects With Change From Normal to Abnormal in Fundus Examination at Any Post-Therapy Visit as Compared to Baseline Assessment
participantsCLG561, Level ACLG561, Level BCLG561, Level CCLG561, Level DCLG561, Level E
Retina: Baseline Normal54465
Retina: Change from Normal to Abnormal10001
Macula: Baseline Normal66666
Macula: Change from Normal to Abnormal00001
Choroid: Baseline Normal66666
Choroid: Change from Normal to Abnormal00000
Optic Nerve: Baseline Normal63565
Optic Nerve: Change from Normal to Abnormal10200
PrimaryNumber 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.

Time frame:
Baseline, Day 2, Day 4, Day 8, Day 15, Day 29, Day 57, Day 85
Reported as:
Number · participants
Number of Subjects With a Change From Normal to Abnormal in Ocular Signs at Any Post-Therapy Visit as Compared to Baseline Assessment
participantsCLG561, Level ACLG561, Level BCLG561, Level CCLG561, Level DCLG561, Level E
Lids/Lashes: Baseline Normal54566
Lids/Lashes: Change from Normal to Abnormal01101
Conjunctiva: Baseline Normal54655
Conjunctiva: Change from Normal to Abnormal21402
Cornea: Baseline Normal65665
Cornea: Change from Normal to Abnormal00201
Iris: Baseline Normal66666
Iris: Change from Normal to Abnormal00000
SecondaryArea 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.

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
Reported as:
Mean · hr*ng/mL
Area Under the Serum Concentration-time Curve (AUC) From Time Zero to All [AUC(0-all)]
hr*ng/mLCLG561, Level ACLG561, Level BCLG561, Level CCLG561, Level DCLG561, Level E
Area Under the Serum Concentration-time Curve (AUC) From Time Zero to All [AUC(0-all)]NA ± NANA ± NANA ± NA238000 ± 81800373000 ± 160000
SecondaryArea 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.

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
Reported as:
Mean · hr*ng/mL
Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-last)]
hr*ng/mLCLG561, Level ACLG561, Level BCLG561, Level CCLG561, Level DCLG561, Level E
Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-last)]NA ± NANA ± NANA ± NA195000 ± 78300304000 ± 148000
SecondaryTime 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.

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
Reported as:
Mean · hours
Time to Reach the Maximum Serum Concentration After Drug Administration (Tmax)
hoursCLG561, Level ACLG561, Level BCLG561, Level CCLG561, Level DCLG561, Level E
Time to Reach the Maximum Serum Concentration After Drug Administration (Tmax)NA ± NANA ± NANA ± NA144 ± 62.7187 ± 79.8
SecondaryDose 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.

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
Reported as:
Mean · ng/mL/mg
Dose Normalized Observed Maximum Serum Concentration Following Drug Administration (Cmax/D)
ng/mL/mgCLG561, Level ACLG561, Level BCLG561, Level CCLG561, Level DCLG561, Level E
Dose Normalized Observed Maximum Serum Concentration Following Drug Administration (Cmax/D)NA ± NANA ± NANA ± NA102 ± 3075.8 ± 30.9
SecondaryDose-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.

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
Reported as:
Mean · hr*ng/mL/mg
Dose-normalized Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-last)/D]
hr*ng/mL/mgCLG561, Level ACLG561, Level BCLG561, Level CCLG561, Level DCLG561, Level E
Dose-normalized Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-last)/D]NA ± NANA ± NANA ± NA38900 ± 1570030400 ± 14800
SecondaryArea 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.

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

No measurements were reported for this outcome.

SecondaryTerminal Elimination Half-life (T½)

Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method.

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

No measurements were reported for this outcome.

SecondaryThe 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.

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

No measurements were reported for this outcome.

SecondaryApparent 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.

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

No measurements were reported for this outcome.

Adverse events

Collected over 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.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
CLG561, Level A—1/6 (16.7%)5/6 (83.3%)
CLG561, Level B—0/6 (0%)3/6 (50%)
CLG561, Level C—1/7 (14.3%)6/7 (85.7%)
CLG561, Level D—0/6 (0%)2/6 (33.3%)
CLG561, Level E—0/6 (0%)3/6 (50%)
Pretreatment—0/50 (0%)0/50 (0%)
Most frequent serious events
Most frequent serious events
EventCLG561, Level ACLG561, Level BCLG561, Level CCLG561, Level DCLG561, Level EPretreatment
Blindness TransientEye disorders1/60/61/70/60/60/50
Most frequent other events
Showing 10 of 54
Most frequent other events
EventCLG561, Level ACLG561, Level BCLG561, Level CCLG561, Level DCLG561, Level EPretreatment
Conjunctival haemorrhageEye disorders3/61/63/71/61/60/50
Punctate keratitisEye disorders0/60/63/70/60/60/50
Amylase increasedInvestigations0/62/60/70/60/60/50
Lipase increasedInvestigations0/62/60/70/60/60/50
Conjunctival hyperaemiaEye disorders0/60/62/70/60/60/50
Erythema of eyelidEye disorders0/61/62/70/61/60/50
Optic atrophyEye disorders0/60/62/70/60/60/50
Angina pectorisCardiac disorders0/60/60/70/61/60/50
ConjunctivochalasisEye disorders0/61/60/70/60/60/50
Eye painEye disorders1/60/60/70/60/60/50

Baseline characteristics

This analysis population includes all enrolled subjects who received CLG561.

Age, Continuous
Age, Continuous(years)CLG561, Level ACLG561, Level BCLG561, Level CCLG561, Level DCLG561, Level ETotal
Mean74.2 ± 6.8276.2 ± 8.8076.1 ± 6.6973.3 ± 9.5276.5 ± 10.8675.3 ± 8.12
Sex: Female, Male
Sex: Female, Male(Participants)CLG561, Level ACLG561, Level BCLG561, Level CCLG561, Level DCLG561, Level ETotal
Female6145319
Male0531312
Primary Diagnosis
Primary Diagnosis(participants)CLG561, Level ACLG561, Level BCLG561, Level CCLG561, Level DCLG561, Level ETotal
Geographic atrophy022127
Exudative macular degeneration6455424
08

Study locations

No study locations are listed for this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01835015
Lead sponsor
Alcon Research
Responsible party
Sponsor
First posted
Apr 18, 2013
Start date
May 2013
Primary completion
Nov 2014
Completion
Nov 2014
Results posted
Mar 25, 2016
Last update
Mar 25, 2016

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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