8/2/2021
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`A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary t…
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`Trial record 3 of 3 for: lampalizumab | Phase 3
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`
`A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal
`Injections in Participants With Geographic Atrophy Secondary to Age-Related
`Macular Degeneration (CHROMA)
`
`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 evaluated by the U.S.
`Federal Government. Read our disclaimer for details.
`
`
`ClinicalTrials.gov Identifier: NCT02247479
`
`Recruitment Status  : Terminated
`First Posted  : September 25, 2014
`Results First Posted  : April 23, 2019
`Last Update Posted  : June 26, 2019
`
`Sponsor:
`Hoffmann-La Roche
`
`Information provided by (Responsible Party):
`
`https://clinicaltrials.gov/ct2/show/NCT02247479?term=lampalizumab&phase=2&draw=2&rank=3
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`8/2/2021
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`A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary t…
`Hoffmann-La Roche
`
`Study Details
`
`Tabular View
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`Study Results
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`Disclaimer
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`How to Read a Study Record
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`Study Description
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`Go to
`
`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).
`
`Condition or disease 
`
`Intervention/treatment 
`
`Geographic Atrophy
`
`Drug: Lampalizumab
`
`Phase 
`
`Phase 3
`
`Other: Sham
`
`Study Design
`
`Go to
`
`Study Type  :
`Interventional (Clinical Trial)
`Actual Enrollment  :
`906 participants
`Allocation:
`Randomized
`Intervention Model:
`Parallel Assignment
`Masking:
`Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
`Primary Purpose:
`Treatment
`Official 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
`Actual Study Start Date  :
`September 18, 2014
`
`https://clinicaltrials.gov/ct2/show/NCT02247479?term=lampalizumab&phase=2&draw=2&rank=3
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`A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary t…
`
`Actual Primary Completion Date  :
`January 29, 2018
`Actual Study Completion Date  :
`January 29, 2018
`
`Resource links provided by the National Library of Medicine
`
`MedlinePlus Genetics related topics: Age-related macular degeneration
`
`MedlinePlus related topics: Macular Degeneration
`
`U.S. FDA Resources
`
`Arms and Interventions
`
`Go to
`
`Arm 
`
`Intervention/treatment 
`
`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.
`
`Drug: Lampalizumab
`Participants will receive 10 mg dose of
`lampalizumab administered intravitreally.
`Other Name: RO5490249
`
`Experimental: Lampalizumab Once in Every 6
`Weeks (Q6W)
`Participants will receive 10 mg dose of
`lampalizumab administered by intravitreal
`injections for approximately 96 weeks.
`
`Drug: Lampalizumab
`Participants will receive 10 mg dose of
`lampalizumab administered intravitreally.
`Other Name: RO5490249
`
`Sham Comparator: Sham Comparator
`Participants will receive sham comparator Q4W or
`Q6W for 96 weeks.
`
`Other: Sham
`A sham injection is a procedure that mimics an
`intravitreal injection of lampalizumab.
`
`Outcome Measures
`
`Go to
`
`Primary Outcome Measures  :
`1. Change From Baseline in Geographic Atrophy (GA) Area, as Assessed by Fundus Autofluoresence
`(FAF) at Week 48 [ Time Frame: Baseline, Week 48 ]
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`A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary t…
`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).
`
`2. Change From Baseline in GA Area in Complement Factor I (CFI) Positive and Negative Participants at
`Week 48 [ Time Frame: Baseline, Week 48 ]
`
`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).
`
`Secondary Outcome Measures  :
`1. Change From Baseline in Number of Absolute Scotomatous Points as Assessed by Mesopic
`Micrometry at Week 48 [ Time Frame: Baseline, Week 48 ]
`
`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.
`
`2. Change From Baseline in Mean Macular Sensitivity as Assessed by Mesopic Microperimetry at
`Week 48 [ Time Frame: Baseline, Week 48 ]
`
`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.
`
`3. Change From Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early
`Treatment Diabetic Retinopathy Study (ETDRS) Chart at Week 48 [ Time Frame: Baseline, Week
`48 ]
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`A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary t…
`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.
`
`4. Percentage of Participants With Less Than 15 Letters Loss From Baseline in BCVA Score at Week
`48 [ Time Frame: Week 48 ]
`
`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.
`
`5. Change From Baseline in Low Luminance Visual Acuity (LLVA) as Assessed by ETDRS Chart Under
`Low Luminance Conditions at Week 48 [ Time Frame: Baseline, Week 48 ]
`
`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.
`
`6. Percentage of Participants With Less Than 15 Letters Loss From Baseline in LLVA Score at Week
`48 [ Time Frame: Week 48 ]
`
`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.
`
`7. Change From Baseline in Binocular Reading Speed as Assessed by Minnesota Low-Vision Reading
`Test (MNRead) Charts or Radner Reading Charts at Week 48 [ Time Frame: Baseline, Week 48 ]
`
`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
`
`https://clinicaltrials.gov/ct2/show/NCT02247479?term=lampalizumab&phase=2&draw=2&rank=3
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`8/2/2021
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`A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary t…
`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.
`
`8. Change From Baseline in Monocular Maximum Reading Speed as Assessed by MNRead Charts or
`Radner Reading Charts at Week 48 [ Time Frame: Baseline, Week 48 ]
`
`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.
`
`9. Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item (NEI
`VFQ-25) Version Composite Score at Week 48 [ Time Frame: Baseline, Week 48 ]
`
`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.
`
`10. Change From Baseline in NEI VFQ-25 Near Activity Subscale Score at Week 48
`[ Time Frame: Baseline, Week 48 ]
`
`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.
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`A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary t…
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`11. Change From Baseline in NEI VFQ-25 Distance Activity Subscale Score at Week 48
`[ Time Frame: Baseline, Week 48 ]
`
`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.
`
`12. Change From Baseline in Mean Functional Reading Independence (FRI) Index at Week 48
`[ Time Frame: Baseline, Week 48 ]
`
`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.
`
`Eligibility Criteria
`
`Go to
`
`Information from the National Library of Medicine
`
`Choosing to participate in a study is an important personal decision. Talk with your doctor and family
`members or friends about deciding to join a study. To learn more about this study, you or your doctor may
`contact the study research staff using the contacts provided below. For general information, Learn About
`Clinical Studies.
`
`Ages Eligible for Study:
`50 Years and older (Adult, Older Adult)
`Sexes Eligible for Study:
`All
`
`https://clinicaltrials.gov/ct2/show/NCT02247479?term=lampalizumab&phase=2&draw=2&rank=3
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`8/2/2021
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`A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary t…
`
`Accepts Healthy Volunteers:
`No
`
`Criteria
`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
`
`Exclusion Criteria:
`
`Ocular Exclusion Criteria: 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 Exclusion Criteria: Both Eyes
`GA in either eye due to causes other than AMD
`Previous treatment with eculizumab, lampalizumab and/or fenretinide
`
`Contacts and Locations
`
`Go to
`
`Information from the National Library of Medicine
`
`To learn more about this study, you or your doctor may contact the study research staff using the contact
`information provided by the sponsor.
`
`Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247479
`
`Locations
`
` Show 145 study locations
`
`Sponsors and Collaborators
`Hoffmann-La Roche
`
`Investigators
`Study Director: Clinical Trials Hoffmann-La Roche
`
`https://clinicaltrials.gov/ct2/show/NCT02247479?term=lampalizumab&phase=2&draw=2&rank=3
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`A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary t…
` Study Documents (Full-Text)
`
`Documents provided by Hoffmann-La Roche:
`
`Statistical Analysis Plan [PDF] October 2, 2017
`
`Study Protocol [PDF] September 24, 2015
`
`More Information
`
`Go to
`
`Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
`
`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.
`
`Responsible Party:
`Hoffmann-La Roche
`ClinicalTrials.gov Identifier:
`NCT02247479 History of Changes
`Other Study ID Numbers:
`GX29176
`2014-000107-27 ( EudraCT Number )
`First Posted:
`September 25, 2014 Key Record Dates
`Results First Posted:
`April 23, 2019
`
`https://clinicaltrials.gov/ct2/show/NCT02247479?term=lampalizumab&phase=2&draw=2&rank=3
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`8/2/2021
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`A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary t…
`
`Last Update Posted:
`June 26, 2019
`Last Verified:
`June 2019
`
`Studies a U.S. FDA-regulated Drug Product:
`Yes
`Studies a U.S. FDA-regulated Device Product:
`No
`
`Additional relevant MeSH terms:
`Macular Degeneration
`Geographic Atrophy
`Atrophy
`Retinal Degeneration
`Retinal Diseases
`Eye Diseases
`Pathological Conditions, Anatomical
`
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