Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
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
Query!
Secondary ID [1]
0
0
2014-000107-27
Query!
Secondary ID [2]
0
0
GX29176
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
CHROMA
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Geographic Atrophy
0
0
Query!
Condition category
Condition code
Eye
0
0
0
0
Query!
Diseases / disorders of the eye
Query!
Other
0
0
0
0
Query!
Research that is not of generic health relevance and not applicable to specific health categories listed above
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Intervention code [2]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Change From Baseline in Geographic Atrophy (GA) Area, as Assessed by Fundus Autofluoresence (FAF) at Week 48
Query!
Assessment method [1]
0
0
The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).
Query!
Timepoint [1]
0
0
Baseline, Week 48
Query!
Primary outcome [2]
0
0
Change From Baseline in GA Area in Complement Factor I (CFI) Positive and Negative Participants at Week 48
Query!
Assessment method [2]
0
0
For CFI profile, positive or negative biomarker status refers to the presence (carrier) or absence of the risk allele at CFI and at least one risk allele at complement factor H (CFH) or risk locus containing both complement component 2 and complement factor B (C2/CFB).The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).
Query!
Timepoint [2]
0
0
Baseline, Week 48
Query!
Secondary outcome [1]
0
0
Change From Baseline in Number of Absolute Scotomatous Points as Assessed by Mesopic Micrometry at Week 48
Query!
Assessment method [1]
0
0
Scotomatous points were the testing points on microperimetry examination that were centered on the macula and reported a lack of retinal sensitivity within the range tested, a maximum of 68 points were tested within this range. Higher results indicate expansion of absolute scotoma and higher number of abolute scotomatous points. Mesopic microperimetry assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. A positive change from baseline indicates an increase in the number of absolute scotomatous points (more lack of retinal sensitivity); disease worsening.
Query!
Timepoint [1]
0
0
Baseline, Week 48
Query!
Secondary outcome [2]
0
0
Change From Baseline in Mean Macular Sensitivity as Assessed by Mesopic Microperimetry at Week 48
Query!
Assessment method [2]
0
0
Mesopic microperimetry was used to assess macular sensitivity and assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. A negative change from baseline indicates a decrease in the mean macular sensitivity; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
Query!
Timepoint [2]
0
0
Baseline, Week 48
Query!
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
Query!
Assessment method [3]
0
0
BCVA score was based on the number of letters read correctly on the ETDRS visual acuity chart assessed at a starting distance of 4 meters (m). BCVA score testing was performed prior to dilating the eyes. BCVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A negative change from baseline indicates a decrease in the visual acuity; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
Query!
Timepoint [3]
0
0
Baseline, Week 48
Query!
Secondary outcome [4]
0
0
Percentage of Participants With Less Than 15 Letters Loss From Baseline in BCVA Score at Week 48
Query!
Assessment method [4]
0
0
Loss of less than 15 letters from baseline was assessed by the ETDRS chart at a starting distance of 4 meters (m). BCVA was measured using an eye chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
Query!
Timepoint [4]
0
0
Week 48
Query!
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
Query!
Assessment method [5]
0
0
The LLVA was measured by placing a 2.0-log-unit neutral density filter over the best correction for that eye and having the participant read the normally illuminated ETDRS chart. The assessment was performed prior to dilating the eyes. LLVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
Query!
Timepoint [5]
0
0
Baseline, Week 48
Query!
Secondary outcome [6]
0
0
Percentage of Participants With Less Than 15 Letters Loss From Baseline in LLVA Score at Week 48
Query!
Assessment method [6]
0
0
Loss of less than 15 letters from baseline was assessed by the ETDRS chart at a starting distance of 4 m. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
Query!
Timepoint [6]
0
0
Week 48
Query!
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
Query!
Assessment method [7]
0
0
MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring the reading acuity and reading speed of normal and low-vision participants. The MNRead acuity cards consisted of single, simple sentences with equal numbers of characters. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. The Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. The reading test was stopped when the reading time was longer than 20 seconds or when the participant was making severe errors. A negative change from baseline indicates a decrease in the binocular reading speed; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
Query!
Timepoint [7]
0
0
Baseline, Week 48
Query!
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
Query!
Assessment method [8]
0
0
MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring the reading acuity and reading speed of normal and low-vision participants. The MNRead acuity cards consisted of single, simple sentences with equal numbers of characters. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. The Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. The reading test was stopped when the reading time was longer than 20 seconds or when the participant was making severe errors. A negative change from baseline indicates a decrease in the monocular reading speed; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
Query!
Timepoint [8]
0
0
Baseline, Week 48
Query!
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
Query!
Assessment method [9]
0
0
NEI-VFQ-25 questionnaire included 25 items based on which overall composite VFQ score and 12 subscales were derived: near activities, distance activities, general health,general vision, ocular pain, vision-specific social functioning, vision-specific mental health, vision-specific role difficulties, vision-specific dependency, driving, color vision and peripheral vision. Response to each question converted to 0-100 score. Each subscale, total score=average of items contributing to score. For each subscale and total score, score range: 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the visual functioning; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
Query!
Timepoint [9]
0
0
Baseline, Week 48
Query!
Secondary outcome [10]
0
0
Change From Baseline in NEI VFQ-25 Near Activity Subscale Score at Week 48
Query!
Assessment method [10]
0
0
NEI-VFQ-25 questionnaire included 25 items based on which near activities were measured. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the near visual activities; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
Query!
Timepoint [10]
0
0
Baseline, Week 48
Query!
Secondary outcome [11]
0
0
Change From Baseline in NEI VFQ-25 Distance Activity Subscale Score at Week 48
Query!
Assessment method [11]
0
0
NEI-VFQ-25 questionnaire included 25 items based on which distance activities were measured. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the distance visual activities; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
Query!
Timepoint [11]
0
0
Baseline, Week 48
Query!
Secondary outcome [12]
0
0
Change From Baseline in Mean Functional Reading Independence (FRI) Index at Week 48
Query!
Assessment method [12]
0
0
The FRI was an interviewer-administered questionnaire with 7 items on functional reading activities most relevant to GA AMD participants. It has one total index score. For each FRI Index reading activity performed in the past 7 days, participants were asked about the extent to which they required vision aids, adjustments in the activity, or help from another participant. Mean FRI Index scores range from 1 to 4, with higher scores indicating greater independence. A negative change from baseline indicates a decrease in the FRI; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
Query!
Timepoint [12]
0
0
Baseline, Week 48
Query!
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
Query!
Minimum age
50
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Stopped early
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
18/09/2014
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
29/01/2018
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
906
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
0
0
Eyeclinic Albury Wodonga - Albury
Query!
Recruitment hospital [2]
0
0
Marsden Eye Research Centre - Parramatta
Query!
Recruitment hospital [3]
0
0
Save Sight Institute - Sydney
Query!
Recruitment hospital [4]
0
0
Sydney West Retina - Westmead
Query!
Recruitment postcode(s) [1]
0
0
2640 - Albury
Query!
Recruitment postcode(s) [2]
0
0
2150 - Parramatta
Query!
Recruitment postcode(s) [3]
0
0
2000 - Sydney
Query!
Recruitment postcode(s) [4]
0
0
2145 - Westmead
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Georgia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Hawaii
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Illinois
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Indiana
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Iowa
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Kansas
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Kentucky
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Maine
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Maryland
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Massachusetts
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Michigan
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Nebraska
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Nevada
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
New Jersey
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
New York
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
North Carolina
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Ohio
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Pennsylvania
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
South Carolina
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Tennessee
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Texas
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Utah
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Virginia
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Washington
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
West Virginia
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Wisconsin
Query!
Country [31]
0
0
Argentina
Query!
State/province [31]
0
0
Buenos Aires
Query!
Country [32]
0
0
Argentina
Query!
State/province [32]
0
0
Caba
Query!
Country [33]
0
0
Argentina
Query!
State/province [33]
0
0
Mendoza
Query!
Country [34]
0
0
Argentina
Query!
State/province [34]
0
0
Rosario
Query!
Country [35]
0
0
Austria
Query!
State/province [35]
0
0
Linz
Query!
Country [36]
0
0
Belgium
Query!
State/province [36]
0
0
Bruxelles
Query!
Country [37]
0
0
Belgium
Query!
State/province [37]
0
0
Gent
Query!
Country [38]
0
0
Belgium
Query!
State/province [38]
0
0
Leuven
Query!
Country [39]
0
0
Belgium
Query!
State/province [39]
0
0
Liège
Query!
Country [40]
0
0
Canada
Query!
State/province [40]
0
0
Alberta
Query!
Country [41]
0
0
Canada
Query!
State/province [41]
0
0
British Columbia
Query!
Country [42]
0
0
Canada
Query!
State/province [42]
0
0
Nova Scotia
Query!
Country [43]
0
0
Canada
Query!
State/province [43]
0
0
Ontario
Query!
Country [44]
0
0
Canada
Query!
State/province [44]
0
0
Quebec
Query!
Country [45]
0
0
Denmark
Query!
State/province [45]
0
0
Roskilde
Query!
Country [46]
0
0
France
Query!
State/province [46]
0
0
Creteil
Query!
Country [47]
0
0
France
Query!
State/province [47]
0
0
Paris
Query!
Country [48]
0
0
France
Query!
State/province [48]
0
0
Poitiers
Query!
Country [49]
0
0
Germany
Query!
State/province [49]
0
0
Bonn
Query!
Country [50]
0
0
Germany
Query!
State/province [50]
0
0
Göttingen
Query!
Country [51]
0
0
Germany
Query!
State/province [51]
0
0
Hannover
Query!
Country [52]
0
0
Germany
Query!
State/province [52]
0
0
Köln
Query!
Country [53]
0
0
Germany
Query!
State/province [53]
0
0
Lübeck
Query!
Country [54]
0
0
Germany
Query!
State/province [54]
0
0
Münster
Query!
Country [55]
0
0
Hungary
Query!
State/province [55]
0
0
Budapest
Query!
Country [56]
0
0
Hungary
Query!
State/province [56]
0
0
Debrecem
Query!
Country [57]
0
0
Hungary
Query!
State/province [57]
0
0
Pecs
Query!
Country [58]
0
0
Italy
Query!
State/province [58]
0
0
Lazio
Query!
Country [59]
0
0
Italy
Query!
State/province [59]
0
0
Lombardia
Query!
Country [60]
0
0
Italy
Query!
State/province [60]
0
0
Sardegna
Query!
Country [61]
0
0
Mexico
Query!
State/province [61]
0
0
Mexico, D.F.
Query!
Country [62]
0
0
Netherlands
Query!
State/province [62]
0
0
Amsterdam
Query!
Country [63]
0
0
Netherlands
Query!
State/province [63]
0
0
Leiden
Query!
Country [64]
0
0
Netherlands
Query!
State/province [64]
0
0
Nijmegen
Query!
Country [65]
0
0
Peru
Query!
State/province [65]
0
0
Lima
Query!
Country [66]
0
0
Poland
Query!
State/province [66]
0
0
Bydgoszcz
Query!
Country [67]
0
0
Poland
Query!
State/province [67]
0
0
Gdansk
Query!
Country [68]
0
0
Poland
Query!
State/province [68]
0
0
Katowice
Query!
Country [69]
0
0
Poland
Query!
State/province [69]
0
0
Krakow
Query!
Country [70]
0
0
Slovakia
Query!
State/province [70]
0
0
Bratislava
Query!
Country [71]
0
0
Slovakia
Query!
State/province [71]
0
0
Trencin
Query!
Country [72]
0
0
Slovakia
Query!
State/province [72]
0
0
Zilina
Query!
Country [73]
0
0
Spain
Query!
State/province [73]
0
0
Barcelona
Query!
Country [74]
0
0
Spain
Query!
State/province [74]
0
0
Guipuzcoa
Query!
Country [75]
0
0
Spain
Query!
State/province [75]
0
0
Alicante
Query!
Country [76]
0
0
Spain
Query!
State/province [76]
0
0
Valencia
Query!
Country [77]
0
0
Spain
Query!
State/province [77]
0
0
Valladolid
Query!
Country [78]
0
0
Switzerland
Query!
State/province [78]
0
0
Zürich
Query!
Country [79]
0
0
United Kingdom
Query!
State/province [79]
0
0
AYR
Query!
Country [80]
0
0
United Kingdom
Query!
State/province [80]
0
0
Edinburgh
Query!
Country [81]
0
0
United Kingdom
Query!
State/province [81]
0
0
Frimley
Query!
Country [82]
0
0
United Kingdom
Query!
State/province [82]
0
0
Sheffield
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Hoffmann-La Roche
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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).
Query!
Trial website
https://clinicaltrials.gov/study/NCT02247479
Query!
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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Clinical Trials
Query!
Address
0
0
Hoffmann-La Roche
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/79/NCT02247479/SAP_000.pdf
Study protocol
https://cdn.clinicaltrials.gov/large-docs/79/NCT02247479/Prot_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02247479
Download to PDF