NCT01835015

Brief 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).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2013

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

April 16, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 18, 2013

Completed
13 days until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

March 25, 2016

Completed
Last Updated

March 25, 2016

Status Verified

February 1, 2016

Enrollment Period

1.5 years

First QC Date

April 16, 2013

Results QC Date

January 12, 2016

Last Update Submit

February 24, 2016

Conditions

Age-related Macular Degeneration

Keywords

First in humanSafetyTolerabilitySerum PKIntravitreal (IVT)Age-related macular degenerationAMDGeographic AtrophyChoroidal neovascularization

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    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)]

    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)]

    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)

    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)

    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]

    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 more secondary outcomes

Study Arms (5)

CLG561, Concentration Level A

EXPERIMENTAL

Single 50 μL intravitreal injection of CLG561, Dose Level A

Drug: CLG561

CLG561, Concentration Level B

EXPERIMENTAL

Single 50 μL intravitreal injection of CLG561, Dose Level B

Drug: CLG561

CLG561, Concentration Level C

EXPERIMENTAL

Single 50 μL intravitreal injection of CLG561, Dose Level C

Drug: CLG561

CLG561, Concentration Level D

EXPERIMENTAL

Single 50 μL intravitreal injection of CLG561, Dose Level D

Drug: CLG561

CLG561, Concentration Level E

EXPERIMENTAL

Single 100 μL intravitreal injection of CLG561, Dose Level E

Drug: CLG561

Interventions

CLG561DRUG

Administered by intravitreal injection, Day 1

CLG561, Concentration Level ACLG561, Concentration Level BCLG561, Concentration Level CCLG561, Concentration Level DCLG561, Concentration Level E

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Macular DegenerationGeographic AtrophyChoroidal Neovascularization

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesChoroid DiseasesUveal DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Director, Translational Medicine Expert, Ophthalmology
Organization
Alcon Research, Ltd.
alcon.medinfo@alcon.com
1-888-451-3937

Study Officials

  • Head of Clinical Sciences, CA CSI NS/Opth

    Alcon Research

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2013

First Posted

April 18, 2013

Study Start

May 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

March 25, 2016

Results First Posted

March 25, 2016

Record last verified: 2016-02