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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02247531




Registration number
NCT02247531
Ethics application status
Date submitted
15/07/2014
Date registered
25/09/2014
Date last updated
15/10/2019

Titles & IDs
Public title
A Study Investigating the Safety and Efficacy 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
2014-000106-35
Secondary ID [2] 0 0
GX29185
Universal Trial Number (UTN)
Trial acronym
SPECTRI
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 Comparator

Experimental: Lampalizumab once in every 4 weeks (Q4W) - Participants will receive 10 mg (milligrams) dose of lampalizumab by intravitreal injection, Q4W, starting at the Day 1 visit for approximately 92 weeks.

Experimental: Lampalizumab once in every 6 weeks (Q6W) - Participants will receive 10 mg dose of lampalizumab by intravitreal injection, Q6W, starting at the Day 1 visit for approximately 90 weeks.

Sham comparator: Sham Comparator - Participants will receive sham comparator, Q4W, starting at the Day 1 visit for approximately 92 weeks or Q6W, starting at the Day 1 visit for approximately 90 weeks.


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

Other interventions: Sham Comparator
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 Atropy (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 Assessed by Mesopic Microperimetry at Week 48
Timepoint [1] 0 0
Baseline, Week 48
Secondary outcome [2] 0 0
Change From Baseline in 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
* Participants aged greater than or equal to (>/=) 50 years
* 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 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 (e.g., 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

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
6/10/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/01/2018
Sample size
Target
Accrual to date
Final
975
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Queensland Eye Institute - Brisbane
Recruitment hospital [2] 0 0
Adelaide Eye and Retina Centre - Adelaide
Recruitment hospital [3] 0 0
Vision Eye Institute Eastern - Box Hill
Recruitment hospital [4] 0 0
Royal Victorian Eye and Ear Hospital - East Melbourne
Recruitment hospital [5] 0 0
The Lions Eye Institute - Nedlands
Recruitment postcode(s) [1] 0 0
4101 - Brisbane
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02247531