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Evaluation of AL-78898A in Exudative Age-Related Macular Degeneration (RACE)

Primary Purpose

Exudative Age-Related Macular Degeneration

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AL-78898A
Ranibizumab
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exudative Age-Related Macular Degeneration focused on measuring Wet AMD, Intravitreal Injection, Macular Degeneration, VEGF treatment

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Willing to give informed consent, make the required study visits and follow instructions;
  • Newly diagnosed with exudative age-related macular degeneration (AMD);
  • Presence of primary juxta- or subfoveal choroidal neovascularization (CNV) secondary to AMD (study eye);
  • Best-corrected visual acuity (BCVA) in study eye as specified in protocol;
  • No vision-threatening ocular condition other than AMD, in the opinion of the Investigator;
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • History or current evidence of macular or retinal disease other than exudative AMD (study eye);
  • Any evidence of fibrosis or scarring within the CNV (choroidal neovascularization)lesion (study eye);
  • Any evidence of vitreous hemorrhage (study eye);
  • History or evidence of surgery (study eye), as specified in protocol;
  • Any active systemic infection or ocular/intraocular infection or inflammation in either eye;
  • A history or current medical diagnosis of glaucoma or ocular hypertension (study eye), as specified in protocol;
  • History or current evidence of a medical condition that may in the opinion of the Investigator preclude the safe administration of test article, adherence to the scheduled study visits, safe participation in the study or affect the results of the study
  • History of severe or serious hypersensitivity to any component of the investigational product, reference product or clinically relevant sensitivity to fluorescein dye, as assessed by the Investigator;
  • Females of childbearing potential may not participate in the study if pregnant, lactating, or not using adequate birth control methods for the duration of the study;
  • Participation in any ocular or non-ocular investigational study within 30 days of screening;
  • Has received any approved or investigational therapy for AMD in the study eye with the exception of vitamins;
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

  • Contact Alcon Call Center for Trial Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AL-78898A

Lucentis

Arm Description

Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up

Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up

Outcomes

Primary Outcome Measures

Mean Reduction From Baseline in Central Subfield (CSF) Retinal Thickness at Week 4
The thickness of the retina was measured using a non-invasive device that produces cross-sectional and 3D images of the eye. The reduction was calculated by subtracting Week 4 visit value from the Baseline value. A positive number indicates a reduction in thickness compared to baseline, whereas a negative number indicates an increase in thickness. An increase in thickness as compared to baseline may indicate a progression of the underlying disease.
Incidence of Events of Special Interest (ESI)
An ESI was a protocol-specified event of scientific and medical concern specific to the Sponsor's product or program where ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. These adverse events could have been serious or nonserious and may have required further investigation in order to characterize and understand.

Secondary Outcome Measures

Full Information

First Posted
July 2, 2010
Last Updated
April 19, 2013
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT01157065
Brief Title
Evaluation of AL-78898A in Exudative Age-Related Macular Degeneration
Acronym
RACE
Official Title
Controlled, Double-Masked, Randomized, Multicenter Study to Evaluate AL-78898A as a Treatment of Exudative AMD
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary purpose of this study was to demonstrate a biological effect of AL-78898A, as measured by change (reduction) in central subfield (CSF) retinal thickness 4 weeks after a single intravitreal injection, as compared to LUCENTIS.
Detailed Description
The study consisted of a Screening Visit (Visit 1), a Day 0 visit (Visit 2), 6 on-therapy visits at Day 1, Weeks 1, 2, 3, 4, and 8 (Visits 3-8), and an Exit Visit at Week 12 (Visit 9). Patients who met all inclusion and exclusion criteria at Visit 1 were randomized in a 3:1 ratio to receive either AL-78898A or LUCENTIS as a single 50-μL injection in the study eye. Additionally, patients received standard therapy for exudative AMD beginning at Week 2/Visit 5 if the patient was not improving per protocol-specified criteria. Beginning at Week 4/Visit 7, patients not improving received standard therapy for exudative AMD at the investigator's discretion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exudative Age-Related Macular Degeneration
Keywords
Wet AMD, Intravitreal Injection, Macular Degeneration, VEGF treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AL-78898A
Arm Type
Experimental
Arm Description
Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
Arm Title
Lucentis
Arm Type
Active Comparator
Arm Description
Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
Intervention Type
Drug
Intervention Name(s)
AL-78898A
Intervention Description
Investigational treatment
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
LUCENTIS®
Intervention Description
Anti-vascular endothelial growth factor (VEGF) treatment
Primary Outcome Measure Information:
Title
Mean Reduction From Baseline in Central Subfield (CSF) Retinal Thickness at Week 4
Description
The thickness of the retina was measured using a non-invasive device that produces cross-sectional and 3D images of the eye. The reduction was calculated by subtracting Week 4 visit value from the Baseline value. A positive number indicates a reduction in thickness compared to baseline, whereas a negative number indicates an increase in thickness. An increase in thickness as compared to baseline may indicate a progression of the underlying disease.
Time Frame
Week 4
Title
Incidence of Events of Special Interest (ESI)
Description
An ESI was a protocol-specified event of scientific and medical concern specific to the Sponsor's product or program where ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. These adverse events could have been serious or nonserious and may have required further investigation in order to characterize and understand.
Time Frame
Up to Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Willing to give informed consent, make the required study visits and follow instructions; Newly diagnosed with exudative age-related macular degeneration (AMD); Presence of primary juxta- or subfoveal choroidal neovascularization (CNV) secondary to AMD (study eye); Best-corrected visual acuity (BCVA) in study eye as specified in protocol; No vision-threatening ocular condition other than AMD, in the opinion of the Investigator; Other protocol-specified inclusion criteria may apply. Exclusion Criteria: History or current evidence of macular or retinal disease other than exudative AMD (study eye); Any evidence of fibrosis or scarring within the CNV (choroidal neovascularization)lesion (study eye); Any evidence of vitreous hemorrhage (study eye); History or evidence of surgery (study eye), as specified in protocol; Any active systemic infection or ocular/intraocular infection or inflammation in either eye; A history or current medical diagnosis of glaucoma or ocular hypertension (study eye), as specified in protocol; History or current evidence of a medical condition that may in the opinion of the Investigator preclude the safe administration of test article, adherence to the scheduled study visits, safe participation in the study or affect the results of the study History of severe or serious hypersensitivity to any component of the investigational product, reference product or clinically relevant sensitivity to fluorescein dye, as assessed by the Investigator; Females of childbearing potential may not participate in the study if pregnant, lactating, or not using adequate birth control methods for the duration of the study; Participation in any ocular or non-ocular investigational study within 30 days of screening; Has received any approved or investigational therapy for AMD in the study eye with the exception of vitamins; Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehdi Hosseini
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Contact Alcon Call Center for Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States

12. IPD Sharing Statement

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Evaluation of AL-78898A in Exudative Age-Related Macular Degeneration

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