Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02745119




Registration number
NCT02745119
Ethics application status
Date submitted
18/04/2016
Date registered
20/04/2016
Date last updated
6/03/2019

Titles & IDs
Public title
Long-Term Safety of Lampalizumab Intravitreal (ITV) Injections in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (OMASPECT)
Scientific title
A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Lampalizumab in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration Who Have Completed a Roche-Sponsored Study
Secondary ID [1] 0 0
2016-000423-13
Secondary ID [2] 0 0
GX30191
Universal Trial Number (UTN)
Trial acronym
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

Experimental: Lampalizumab Every 4 Weeks - Participants who received either lampalizumab or sham comparator every 4 weeks in one of the parent studies and completed the Week 96 visit will receive open-label lampalizumab as 10 milligrams (mg) via ITV injection, administered every 4 weeks.

Experimental: Lampalizumab Every 6 Weeks - Participants who received either lampalizumab or sham comparator every 6 weeks in one of the parent studies and completed the Week 96 visit will receive open-label lampalizumab as 10 mg via ITV injection, administered every 6 weeks.


Treatment: Drugs: Lampalizumab
Lampalizumab 10 mg will be administered every 4 or 6 weeks according to the frequency given during participation in the parent study.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Ocular Adverse Events (AEs) by Severity
Timepoint [1] 0 0
Up to approximately one year
Primary outcome [2] 0 0
Percentage of Participants With Systemic (Non-Ocular) AEs by Severity
Timepoint [2] 0 0
Up to approximately one year
Primary outcome [3] 0 0
Percentage of Participants With Anti-Lampalizumab Antibodies
Timepoint [3] 0 0
Week 48

Eligibility
Key inclusion criteria
* Previous enrollment in Studies GX29176 (NCT02247479) or GX29185 (NCT02247531) with completion of treatment and the Week 96 visit
* Agreement to remain abstinent or use a reliable form of contraception among all men and among women of child-bearing potential
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Concurrent ocular conditions that contraindicate use of lampalizumab or might affect interpretation of study results or that might increase the risk of treatment complications
* Concurrent disease, metabolic dysfunction, or physical or laboratory finding that contraindicates use of lampalizumab or might affect interpretation of study results or that might increase the risk of treatment complications
* Increased risk of infection
* Pregnancy or lactation

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



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
21/07/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/01/2018
Sample size
Target
Accrual to date
Final
994
Recruitment in Australia
Recruitment state(s)
NSW,VIC
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 hospital [5] 0 0
Vision Eye Institute Eastern - Box Hill
Recruitment hospital [6] 0 0
Royal Victorian Eye and Ear Hospital - East Melbourne
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 postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Hawaii
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Iowa
Country [11] 0 0
United States of America
State/province [11] 0 0
Kansas
Country [12] 0 0
United States of America
State/province [12] 0 0
Kentucky
Country [13] 0 0
United States of America
State/province [13] 0 0
Maine
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Massachusetts
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
Country [17] 0 0
United States of America
State/province [17] 0 0
Minnesota
Country [18] 0 0
United States of America
State/province [18] 0 0
Missouri
Country [19] 0 0
United States of America
State/province [19] 0 0
Nevada
Country [20] 0 0
United States of America
State/province [20] 0 0
New Jersey
Country [21] 0 0
United States of America
State/province [21] 0 0
New York
Country [22] 0 0
United States of America
State/province [22] 0 0
North Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
Ohio
Country [24] 0 0
United States of America
State/province [24] 0 0
Oregon
Country [25] 0 0
United States of America
State/province [25] 0 0
Pennsylvania
Country [26] 0 0
United States of America
State/province [26] 0 0
South Carolina
Country [27] 0 0
United States of America
State/province [27] 0 0
South Dakota
Country [28] 0 0
United States of America
State/province [28] 0 0
Tennessee
Country [29] 0 0
United States of America
State/province [29] 0 0
Texas
Country [30] 0 0
United States of America
State/province [30] 0 0
Utah
Country [31] 0 0
United States of America
State/province [31] 0 0
Virginia
Country [32] 0 0
United States of America
State/province [32] 0 0
Washington
Country [33] 0 0
United States of America
State/province [33] 0 0
West Virginia
Country [34] 0 0
United States of America
State/province [34] 0 0
Wisconsin
Country [35] 0 0
Austria
State/province [35] 0 0
Linz
Country [36] 0 0
Austria
State/province [36] 0 0
Wien
Country [37] 0 0
Belgium
State/province [37] 0 0
Bruxelles
Country [38] 0 0
Belgium
State/province [38] 0 0
Leuven
Country [39] 0 0
Canada
State/province [39] 0 0
Quebec
Country [40] 0 0
Denmark
State/province [40] 0 0
Glostrup
Country [41] 0 0
Denmark
State/province [41] 0 0
Roskilde
Country [42] 0 0
France
State/province [42] 0 0
Bordeaux
Country [43] 0 0
France
State/province [43] 0 0
Creteil
Country [44] 0 0
France
State/province [44] 0 0
Lyon
Country [45] 0 0
France
State/province [45] 0 0
Marseille
Country [46] 0 0
France
State/province [46] 0 0
Nantes
Country [47] 0 0
France
State/province [47] 0 0
Paris
Country [48] 0 0
Germany
State/province [48] 0 0
Bonn
Country [49] 0 0
Germany
State/province [49] 0 0
Freiburg
Country [50] 0 0
Germany
State/province [50] 0 0
Hannover
Country [51] 0 0
Germany
State/province [51] 0 0
Heidelberg
Country [52] 0 0
Germany
State/province [52] 0 0
Köln
Country [53] 0 0
Germany
State/province [53] 0 0
Ludwigshafen
Country [54] 0 0
Germany
State/province [54] 0 0
Lübeck
Country [55] 0 0
Germany
State/province [55] 0 0
München
Country [56] 0 0
Germany
State/province [56] 0 0
Münster
Country [57] 0 0
Germany
State/province [57] 0 0
Regensburg
Country [58] 0 0
Germany
State/province [58] 0 0
Tuebingen
Country [59] 0 0
Hungary
State/province [59] 0 0
Budapest
Country [60] 0 0
Hungary
State/province [60] 0 0
Debrecem
Country [61] 0 0
Hungary
State/province [61] 0 0
Pecs
Country [62] 0 0
Italy
State/province [62] 0 0
Lazio
Country [63] 0 0
Italy
State/province [63] 0 0
Liguria
Country [64] 0 0
Italy
State/province [64] 0 0
Lombardia
Country [65] 0 0
Italy
State/province [65] 0 0
Piemonte
Country [66] 0 0
Italy
State/province [66] 0 0
Veneto
Country [67] 0 0
Netherlands
State/province [67] 0 0
Leiden
Country [68] 0 0
Peru
State/province [68] 0 0
Lima
Country [69] 0 0
Poland
State/province [69] 0 0
Bydgoszcz
Country [70] 0 0
Poland
State/province [70] 0 0
Bytom
Country [71] 0 0
Poland
State/province [71] 0 0
Gdansk
Country [72] 0 0
Poland
State/province [72] 0 0
Katowice
Country [73] 0 0
Poland
State/province [73] 0 0
Krakow
Country [74] 0 0
Poland
State/province [74] 0 0
Wroclaw
Country [75] 0 0
Poland
State/province [75] 0 0
Lódz
Country [76] 0 0
Portugal
State/province [76] 0 0
Coimbra
Country [77] 0 0
Portugal
State/province [77] 0 0
Lisboa
Country [78] 0 0
Slovakia
State/province [78] 0 0
Bratislava
Country [79] 0 0
Slovakia
State/province [79] 0 0
Trencin
Country [80] 0 0
Slovakia
State/province [80] 0 0
Zilina
Country [81] 0 0
Spain
State/province [81] 0 0
Barcelona
Country [82] 0 0
Spain
State/province [82] 0 0
Guipuzcoa
Country [83] 0 0
Spain
State/province [83] 0 0
LA Coruña
Country [84] 0 0
Spain
State/province [84] 0 0
Navarra
Country [85] 0 0
Spain
State/province [85] 0 0
Albacete
Country [86] 0 0
Spain
State/province [86] 0 0
Madrid
Country [87] 0 0
Spain
State/province [87] 0 0
Valencia
Country [88] 0 0
Spain
State/province [88] 0 0
Valladolid
Country [89] 0 0
Switzerland
State/province [89] 0 0
Bern
Country [90] 0 0
Switzerland
State/province [90] 0 0
Binningen
Country [91] 0 0
Switzerland
State/province [91] 0 0
Zürich
Country [92] 0 0
Turkey
State/province [92] 0 0
Ankara
Country [93] 0 0
United Kingdom
State/province [93] 0 0
Belfast
Country [94] 0 0
United Kingdom
State/province [94] 0 0
Bradford
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Bristol
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Cardiff
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Gloucestershire
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Liverpool
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Manchester
Country [100] 0 0
United Kingdom
State/province [100] 0 0
Newcastle upon Tyne
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Southampton
Country [102] 0 0
United Kingdom
State/province [102] 0 0
Wolverhampton
Country [103] 0 0
United Kingdom
State/province [103] 0 0
York

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

Ethics approval
Ethics application status

Summary
Brief summary
This multicenter open-label extension study is designed to evaluate the safety and tolerability of lampalizumab intravitreal injections in participants with GA secondary to age-related macular degeneration (AMD) who completed 96 weeks of treatment in Studies GX29176 (NCT02247479) or GX29185 (NCT02247531). The extension will enroll participants from the parent studies who received investigational lampalizumab, as well as lampalizumab-naive participants exposed to sham comparator. All participants will receive open-label lampalizumab in the present study.
Trial website
https://clinicaltrials.gov/study/NCT02745119
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02745119