A Study Investigating the Safety and Efficacy of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

Geographic Atrophy Clinical Trial

— SPECTRI  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02247531
• Other study ID #: GX29185
• Secondary ID: 2014-000106-35
• Status: Terminated
• Phase: Phase 3
• Start date: October 6, 2014
• Est. completion date: January 23, 2018

Study information

• Verified date: October 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 975
• Est. completion date: January 23, 2018
• Est. primary completion date: January 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Atrophy
• Geographic Atrophy
• Macular Degeneration

Intervention

Drug:
• Lampalizumab
10 mg dose of lampalizumab administered intravitreally.

Other:
• Sham Comparator
A sham injection is a procedure that mimics an intravitreal injection of lampalizumab.

Locations

Country	Name	City	State
Argentina	Instituto de la Vision	Capital Federal
Argentina	Oftalmos	Capital Federal
Argentina	Hospital El Cruce	Florencio Varela
Australia	Adelaide Eye and Retina Centre	Adelaide	South Australia
Australia	Vision Eye Institute Eastern	Box Hill	Victoria
Australia	Queensland Eye Institute	Brisbane	Queensland
Australia	Royal Victorian Eye and Ear Hospital	East Melbourne	Victoria
Australia	The Lions Eye Institute	Nedlands	Western Australia
Austria	Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie	Wien
Belgium	CHU Brugmann (Victor Horta)	Bruxelles
Belgium	UZ Leuven Sint Rafael	Leuven
Denmark	Glostrup Hospital, Øjenafdelingen, Forskningsafsnit Ø37	Glostrup
France	Hopital Pellegrin; Ophtalmologie	Bordeaux
France	CHU Bocage; Ophtalmologie	Dijon
France	Hopital de la croix rousse; Ophtalmologie	Lyon cedex
France	Centre Paradis Monticelli; Ophtalmologie	Marseille
France	Hopital Hotel Dieu Et Hme; Clinique Ophtalmologique	Nantes
France	CHNO des Quinze Vingts; Ophtalmologie	Paris
Germany	Universitätsklinikum Freiburg, Klinik für Augenheilkunde	Freiburg
Germany	Universitätsklinik Heidelberg; Augenklinik	Heidelberg
Germany	Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik	Ludwigshafen
Germany	Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik	Mainz
Germany	Klinikum rechts der Isar der TU München; Augenklinik	München
Germany	LMU Klinikum der Universität, Augenklinik	München
Germany	Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde	Regensburg
Germany	Universitätsklinikum Tübingen	Tuebingen
Hungary	Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR	Budapest
Hungary	Semmelweis Egyetem AOK, Szemeszeti Klinika	Budapest
Hungary	Ganglion Medial Center	Pécs
Italy	Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica	Firenze	Toscana
Italy	UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA	Genova	Liguria
Italy	ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)	Milano	Lombardia
Italy	Irccs Ospedale San Raffaele;U.O. Oculistica	Milano	Lombardia
Italy	A.S.L. to1 Presidio Ospedaliero Sperino Oftalmico	Torino	Piemonte
Italy	A.O. Universitaria S. Maria Della Misericordia Di Udine; Clinica Oculistica	Udine	Veneto
Mexico	Hospital Nuestra Señora de La Luz	Mexico City
Mexico	Hospital Universitario de Monterrey	Monterrey
Mexico	Instituto Mexicano de Oftalmologia I.A.P.	Querétaro
Netherlands	Radboud University Nijmegen Medical Centre; Ophthalmology	Nijmegen
Netherlands	Erasmus Medisch Centrum	Rotterdam
Peru	Centro de Investigacion Oftalmolaser	Lima
Peru	Mácula D&T	Lima
Peru	TG Laser Oftalmica	Lima
Poland	OFTALMIKA Sp. z o.o	Bydgoszcz
Poland	Szpital Specjalistyczny nr 1; Oddzial Okulistyki	Bytom
Poland	Klinika Okulistyczna Jasne Blonia	Lódz
Poland	Uniwersytecki Szpital Kliniczny; Klinika Okulistyki	Wroclaw
Portugal	AIBILI - Association for Innovation and Biomedical Research on Light	Coimbra
Portugal	Espaco Medico Coimbra	Coimbra
Portugal	Hospital de Santa Maria; Servico de Oftalmologia	Lisboa
Portugal	Hospital de Sao Joao; Servico de Oftalmologia	Porto
Russian Federation	SAHI "Republic clinical ophthalmological hospial of Ministry of Heal of Tatarstan Republic"	Kazan
Russian Federation	FSBI "Scientific Research Institute of Eye Diseases" of Russian Academy of medical Sciences	Moscow
Russian Federation	St. Educ.Inst. of High Prof.Education "Samara State Medical University"; Chair of ophathalmology	Samara
Slovakia	FNsP F. D. Roosevelta Banska Bystrica, II.Ocna klinika SZU	Banska Bystrica
Slovakia	Univerzitna nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda Ocna klinika SZU a UNB	Bratislava
Spain	Hospital Perpetuo Socorro; Servicio de Oftalmología	Albacete
Spain	Instituto de microcirugia ocular	Barcelona
Spain	Hospital Universitario Clínico San Carlos; Servicio de Oftalmologia	Madrid
Spain	VISSUM Madrid Santa Hortensia	Madrid
Spain	Clinica Universitaria de Navarra; Servicio de Oftalmologia	Pamplona	Navarra
Spain	Instituto Oftalmologico Gomez Ulla	Santiago de Compostela	LA Coruña
Spain	Hospital Universitario la Fe: Servicio de Oftalmologia	Valencia
Sweden	St Eriks Eye Hospital	Stockholm
Switzerland	Inselspital Bern, Universitätsklinik für Augenheilkunde	Bern
Switzerland	Vista Klinik Binningen	Binningen
Turkey	Ankara Baskent University Medical Faculty; Department of Ophthalmology	Ankara
Turkey	Ankara University Medical Faculty; Department of Ophthalmology	Ankara
Turkey	Hacettepe University Medical Faculty; Department of Ophthalmology	Ankara
Turkey	Istanbul University Istanbul Medical Faculty; Department of Ophthalmology	Istanbul
Turkey	Dokuz Eylul University Medical Faculty; Department of Ophthalmology	Izmir
Turkey	Ege University Medical Faculty; Department of Ophthalmology	Izmir
United Kingdom	Royal Victoria Hospital	Belfast
United Kingdom	Bradford Royal Infirmary	Bradford
United Kingdom	Bristol Eye Hospital	Bristol
United Kingdom	University Hospital of Wales	Cardiff
United Kingdom	Gloucestershire Hospitals NHS Foundation Trust	Gloucestershire
United Kingdom	Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre	Liverpool
United Kingdom	Kings College Hospital	London
United Kingdom	Moorfields Eye Hospital NHS Foundation Trust	London
United Kingdom	Macular Treatment Centre; Royal Eye Hospital	Manchester
United Kingdom	Hillingdon Hospital	Middx
United Kingdom	Royal Victoria Infirmary	Newcastle upon Tyne
United Kingdom	Southampton General Hospital	Southampton
United Kingdom	The Royal Wolverhampton Hospitals NHS Trust	Wolverhampton
United Kingdom	The York Hospital	York
United States	Retina Res Institute of Texas	Abilene	Texas
United States	University of Michigan, Kellogg Eye Center	Ann Arbor	Michigan
United States	Western Carolina Retinal Associate PA	Asheville	North Carolina
United States	Retina & Vitreous Center of Southern Oregon	Ashland	Oregon
United States	Emory University	Atlanta	Georgia
United States	University of Colorado	Aurora	Colorado
United States	The Retina Care Center	Baltimore	Maryland
United States	Wilmer Eye Institute	Baltimore	Maryland
United States	Vitreoretinal Associates of Washington	Bellevue	Washington
United States	Mass Eye and Ear Infirmary	Boston	Massachusetts
United States	MUSC Storm eye institute	Charleston	South Carolina
United States	Char Eye Ear &Throat Assoc	Charlotte	North Carolina
United States	Univ of Virginia Ophthalmology	Charlottesville	Virginia
United States	Southeastern Retina Associates Chattanooga	Chattanooga	Tennessee
United States	Mid Atlantic Retina - Wills Eye Hospital	Cherry Hill	New Jersey
United States	Midwest Vision Research Foundation	Chesterfield	Missouri
United States	Retina Group of Washington	Chevy Chase	Maryland
United States	Cincinnati Eye Institute	Cincinnati	Ohio
United States	Retina Consultants of Southern	Colorado Springs	Colorado
United States	OSU Eye Physicians & Surgeons	Columbus	Ohio
United States	Texas Retina Associates	Dallas	Texas
United States	Kresge Eye Institute	Detroit	Michigan
United States	Duke University Eye Center; Vitreoretinal	Durham	North Carolina
United States	Vitreoretinal Surgery	Edina	Minnesota
United States	Palmetto Retina Center	Florence	South Carolina
United States	Retina Group of Florida	Fort Lauderdale	Florida
United States	Retina Health Center	Fort Myers	Florida
United States	Retina Consultants of Orange County	Fullerton	California
United States	Charles Retina Institution	Germantown	Tennessee
United States	Colorado Retina Associates, PC	Golden	Colorado
United States	New England Retina Associates	Hamden	Connecticut
United States	Retina Consultants of Houston	Houston	Texas
United States	UCSD Shiley Eye Center	La Jolla	California
United States	Charleston Neuroscience Inst	Ladson	South Carolina
United States	Jules Stein Eye Institute/ UCLA	Los Angeles	California
United States	N CA Retina Vitreous Assoc	Mountain View	California
United States	Bascom Palmer Eye Institute	Naples	Florida
United States	New York Weil Cornell Med Ctr	New York	New York
United States	Vitreous-Retina-Macula	New York	New York
United States	Retinal & Ophthalmic Cons PC	Northfield	New Jersey
United States	UNMC Truhlsen Eye Institute	Omaha	Nebraska
United States	Paducah Retinal Center	Paducah	Kentucky
United States	Byers Eye Insitute at Stanford	Palo Alto	California
United States	Mid Atlantic Retina	Philadelphia	Pennsylvania
United States	Associated Retina Consultants	Phoenix	Arizona
United States	Allegheny Ophthalmic & Orbital	Pittsburgh	Pennsylvania
United States	Oregon HSU; Casey Eye Institute	Portland	Oregon
United States	Retina Northwest	Portland	Oregon
United States	Retina Consultants, San Diego	Poway	California
United States	Black Hills Eye Institute	Rapid City	South Dakota
United States	Sierra Eye Associates	Reno	Nevada
United States	Retina Assoc of Western NY	Rochester	New York
United States	Retinal Consultants Med Group	Sacramento	California
United States	University of California, Davis, Eye Center	Sacramento	California
United States	Retina Vitreous Assoc of FL	Saint Petersburg	Florida
United States	California Retina Consultants	Santa Barbara	California
United States	Southern Vitreoretinal Assoc	Tallahassee	Florida
United States	University of South Florida	Tampa	Florida
United States	Retina Associates of NJ	Teaneck	New Jersey
United States	Scott and White Hospital	Temple	Texas
United States	Retina Consultants of Houston	The Woodlands	Texas
United States	Retina Specialists	Towson	Maryland
United States	Retina Associates Southwest PC	Tucson	Arizona
United States	Bay Area Retina Associates	Walnut Creek	California
United States	Retina Group of New England	Waterford	Connecticut
United States	Wolfe Eye Clinic	West Des Moines	Iowa
United States	Vitreo Retinal Consultants	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Denmark,  France,  Germany,  Hungary,  Italy,  Mexico,  Netherlands,  Peru,  Poland,  Portugal,  Russian Federation,  Slovakia,  Spain,  Sweden,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Geographic Atropy (GA) Area, as Assessed by Fundus Autofluoresence (FAF) at Week 48	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).	Baseline, Week 48
Primary	Change From Baseline in GA Area in Complement Factor I (CFI) Positive and Negative Participants at 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).	Baseline, Week 48
Secondary	Change From Baseline in Number of Absolute Scotomatous Points Assessed by Mesopic Microperimetry at 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. Mesopic microperimetry assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. A positive change from baseline indicates an increase in the number of absolute scotomatous points (more lack of retinal sensitivity); disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.	Baseline, Week 48
Secondary	Change From Baseline in Macular Sensitivity as Assessed by Mesopic Microperimetry at 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. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.	Baseline, Week 48
Secondary	Change From Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Week 48	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). A decrease in the VA score indicates a worsening in visual acuity. BCVA score testing was performed prior to dilating the eyes. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. 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.	Baseline, Week 48
Secondary	Percentage of Participants With Less Than 15 Letters Loss From Baseline in BCVA Score at Week 48	Loss of less than 15 letters from baseline was assessed by the ETDRS chart at a starting distance of 4 meters (m). Data were collected up to Week 48 instead of Week 96, due to early termination of the study.	Week 48
Secondary	Change From Baseline in Low Luminance Visual Acuity (LLVA) as Assessed by ETDRS Chart Under Low Luminance Conditions at Week 48	The low luminance visual acuity 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. A negative change from baseline indicates a decrease in the visual acuity; disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.	Baseline, Week 48
Secondary	Percentage of Participants With Less Than 15 Letters Loss From Baseline in LLVA Score at Week 48	Loss of less than 15 letters from baseline was assessed by the ETDRS chart at a starting distance of 4 m. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.	Week 48
Secondary	Change From Baseline in Binocular Reading Speed as Assessed by Minnesota Low-Vision Reading Test (MNRead) Charts or Radner Reading Charts at 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 binocular reading speed; disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.	Baseline, Week 48
Secondary	Change From Baseline in Monocular Maximum Reading Speed as Assessed by MNRead Charts or Radner Reading Charts at Week 48	MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring reading acuity and reading speed of normal and low-vision participants. 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. Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. Reading test was stopped when reading time was longer than 20 seconds or when 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.	Baseline, Week 48
Secondary	Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item (NEI VFQ-25) Version Composite Score at 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 or total score is the average of items contributing to the score. For each subscale and total score the score range is 0 to 100 with a higher score representing better functioning. A negative change from baseline indicates a decrease in the visual functioning; disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.	Baseline, Week 48
Secondary	Change From Baseline in NEI VFQ-25 Near Activity Subscale Score at 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.	Baseline, Week 48
Secondary	Change From Baseline in NEI VFQ-25 Distance Activity Subscale Score at 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.	Baseline, Week 48
Secondary	Change From Baseline in Mean Functional Reading Independence (FRI) Index at 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.	Baseline, Week 48