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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02247479




Registration number
NCT02247479
Ethics application status
Date submitted
15/07/2014
Date registered
25/09/2014
Date last updated
26/06/2019

Titles & IDs
Public title
A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Scientific title
A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Assess the Efficacy and Safety of Lampalizumab Administered Intravitreally to Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Secondary ID [1] 0 0
2014-000107-27
Secondary ID [2] 0 0
GX29176
Universal Trial Number (UTN)
Trial acronym
CHROMA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Geographic Atrophy 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lampalizumab
Other interventions - Sham

Experimental: Lampalizumab Once in Every 4 Weeks (Q4W) - Participants will receive 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections for approximately 96 weeks.

Experimental: Lampalizumab Once in Every 6 Weeks (Q6W) - Participants will receive 10 mg dose of lampalizumab administered by intravitreal injections for approximately 96 weeks.

Sham comparator: Sham Comparator - Participants will receive sham comparator Q4W or Q6W for 96 weeks.


Treatment: Drugs: Lampalizumab
Participants will receive 10 mg dose of lampalizumab administered intravitreally.

Other interventions: Sham
A sham injection is a procedure that mimics an intravitreal injection of lampalizumab.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Geographic Atrophy (GA) Area, as Assessed by Fundus Autofluoresence (FAF) at Week 48
Timepoint [1] 0 0
Baseline, Week 48
Primary outcome [2] 0 0
Change From Baseline in GA Area in Complement Factor I (CFI) Positive and Negative Participants at Week 48
Timepoint [2] 0 0
Baseline, Week 48
Secondary outcome [1] 0 0
Change From Baseline in Number of Absolute Scotomatous Points as Assessed by Mesopic Micrometry at Week 48
Timepoint [1] 0 0
Baseline, Week 48
Secondary outcome [2] 0 0
Change From Baseline in Mean Macular Sensitivity as Assessed by Mesopic Microperimetry at Week 48
Timepoint [2] 0 0
Baseline, Week 48
Secondary outcome [3] 0 0
Change From Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Week 48
Timepoint [3] 0 0
Baseline, Week 48
Secondary outcome [4] 0 0
Percentage of Participants With Less Than 15 Letters Loss From Baseline in BCVA Score at Week 48
Timepoint [4] 0 0
Week 48
Secondary outcome [5] 0 0
Change From Baseline in Low Luminance Visual Acuity (LLVA) as Assessed by ETDRS Chart Under Low Luminance Conditions at Week 48
Timepoint [5] 0 0
Baseline, Week 48
Secondary outcome [6] 0 0
Percentage of Participants With Less Than 15 Letters Loss From Baseline in LLVA Score at Week 48
Timepoint [6] 0 0
Week 48
Secondary outcome [7] 0 0
Change From Baseline in Binocular Reading Speed as Assessed by Minnesota Low-Vision Reading Test (MNRead) Charts or Radner Reading Charts at Week 48
Timepoint [7] 0 0
Baseline, Week 48
Secondary outcome [8] 0 0
Change From Baseline in Monocular Maximum Reading Speed as Assessed by MNRead Charts or Radner Reading Charts at Week 48
Timepoint [8] 0 0
Baseline, Week 48
Secondary outcome [9] 0 0
Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item (NEI VFQ-25) Version Composite Score at Week 48
Timepoint [9] 0 0
Baseline, Week 48
Secondary outcome [10] 0 0
Change From Baseline in NEI VFQ-25 Near Activity Subscale Score at Week 48
Timepoint [10] 0 0
Baseline, Week 48
Secondary outcome [11] 0 0
Change From Baseline in NEI VFQ-25 Distance Activity Subscale Score at Week 48
Timepoint [11] 0 0
Baseline, Week 48
Secondary outcome [12] 0 0
Change From Baseline in Mean Functional Reading Independence (FRI) Index at Week 48
Timepoint [12] 0 0
Baseline, Week 48

Eligibility
Key inclusion criteria
* Well demarcated area(s) of Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration (AMD) with no evidence of prior or active choroidal neovascularization (CNV) in both eyes
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Ocular Study Eye

* History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
* Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy
* Previous intravitreal drug delivery (intravitreal corticosteroid injection, anti-angiogenic drugs, anti-complement agents, or device implantation) Ocular Both Eyes
* GA in either eye due to causes other than AMD
* Previous treatment with eculizumab, lampalizumab and/or fenretinide

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/09/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/01/2018
Sample size
Target
Accrual to date
Final
906
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Eyeclinic Albury Wodonga - Albury
Recruitment hospital [2] 0 0
Marsden Eye Research Centre - Parramatta
Recruitment hospital [3] 0 0
Save Sight Institute - Sydney
Recruitment hospital [4] 0 0
Sydney West Retina - Westmead
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2150 - Parramatta
Recruitment postcode(s) [3] 0 0
2000 - Sydney
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment outside Australia
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United States of America
State/province [1] 0 0
Alabama
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Arizona
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California
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Georgia
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Hawaii
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Illinois
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Indiana
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Iowa
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Kansas
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Kentucky
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Maine
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Maryland
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Massachusetts
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Michigan
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Nebraska
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Nevada
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New Jersey
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New York
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Ohio
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Pennsylvania
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Tennessee
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West Virginia
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Caba
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Argentina
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Mendoza
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Rosario
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Linz
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Liège
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Lübeck
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Debrecem
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Pecs
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Lazio
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Mexico
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Mexico, D.F.
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Amsterdam
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Leiden
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Netherlands
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Nijmegen
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Peru
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Lima
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Bydgoszcz
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Gdansk
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Krakow
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Bratislava
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Trencin
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Zilina
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Barcelona
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Valencia
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Valladolid
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Switzerland
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Zürich
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AYR
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Edinburgh
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United Kingdom
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Frimley
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United Kingdom
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Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled study evaluating the efficacy and safety of lampalizumab administered by intravitreal injections in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Trial website
https://clinicaltrials.gov/study/NCT02247479
Trial related presentations / publications
Miere A, Capuano V, Kessler A, Zambrowski O, Jung C, Colantuono D, Pallone C, Semoun O, Petit E, Souied E. Deep learning-based classification of retinal atrophy using fundus autofluorescence imaging. Comput Biol Med. 2021 Mar;130:104198. doi: 10.1016/j.compbiomed.2020.104198. Epub 2020 Dec 28.
Heier JS, Pieramici D, Chakravarthy U, Patel SS, Gupta S, Lotery A, Lad EM, Silverman D, Henry EC, Anderesi M, Tschosik EA, Gray S, Ferrara D, Guymer R; Chroma and Spectri Study Investigators. Visual Function Decline Resulting from Geographic Atrophy: Results from the Chroma and Spectri Phase 3 Trials. Ophthalmol Retina. 2020 Jul;4(7):673-688. doi: 10.1016/j.oret.2020.01.019. Epub 2020 Jan 31.
Holz FG, Sadda SR, Busbee B, Chew EY, Mitchell P, Tufail A, Brittain C, Ferrara D, Gray S, Honigberg L, Martin J, Tong B, Ehrlich JS, Bressler NM; Chroma and Spectri Study Investigators. Efficacy and Safety of Lampalizumab for Geographic Atrophy Due to Age-Related Macular Degeneration: Chroma and Spectri Phase 3 Randomized Clinical Trials. JAMA Ophthalmol. 2018 Jun 1;136(6):666-677. doi: 10.1001/jamaophthalmol.2018.1544.
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02247479