An Extension Study to Evaluate the Long-Term Safety of Lampalizumab in Participants With Geographic Atrophy

Geographic Atrophy Clinical Trial

Official title:

A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Lampalizumab (FCFD4514S) in Patients With Geographic Atrophy Who Have Completed Genentech-Sponsored Lampalizumab Studies

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01602120
• Other study ID #: GX28198
• Secondary ID: 2012-000578-41
• Status: Terminated
• Phase: Phase 2
• Start date: May 29, 2012
• Est. completion date: February 9, 2018

Study information

• Verified date: September 2019
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, open-label extension study of safety and tolerability of lampalizumab administered by intravitreal (ITV) injection to participants with geographic atrophy (GA) who have completed the 18-month treatment in Study CFD4870g (GX01456) (NCT01229215) or 24-week treatment in Study GX29455 (NCT02288559).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 159
• Est. completion date: February 9, 2018
• Est. primary completion date: November 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 89 Years

Eligibility

Inclusion Criteria:

• For CFD4870g participants: Previous enrollment and completion (Month 18 visit) of Study CFD4870g without early treatment discontinuation (lampalizumab or sham)

• For GX29455 participants: Previous enrollment and completion (Week 24 visit) of Study GX29455 without early treatment discontinuation (lampalizumab or sham)

• Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit quality fundus imaging

Exclusion Criteria:

• Early treatment and/or study discontinuation prior to completion of study CFD4870g (GX01456) and GX29455

• Vitrectomy surgery, submacular surgery, or other surgical intervention for age-related macular degeneration (AMD) in the study eye

• Subfoveal focal laser photocoagulation in the study eye

• Treatment with Visodyne, external-beam radiation therapy, or transpupillary thermotherapy in the study eye

• Intravitreally (ITV) drug delivery (e.g., ITV corticosteroid injection, anti-angiogenic drugs, anticomplement drugs, or device implantation) in the study eye. Lampalizumab in study eye and ranibizumab in either eye are permitted

• Any concurrent ocular or intraocular condition in the study eye that contraindicates the use of an investigational drug or may affect interpretation of the study results or may render the participant at high risk for treatment complications

Related Conditions & MeSH terms

• Atrophy
• Geographic Atrophy

Intervention

Drug:
• Lampalizumab
Lampalizumab 10 mg ITV injections as per the schedule specified in respective arms.

Locations

Country	Name	City	State
Germany	Universitatsklinikum Bonn; Medizinische Klinik und Poliklinik III	Bonn
Germany	Universitätsklinikum Freiburg	Freiburg
Germany	Universitatsklinikum Leipzig	Leipzig
Germany	St. Franziskus Hospital	Munster
Germany	Universitätsklinikum Tübingen	Tuebingen
United States	W Texas Retina Consultants PA	Abilene	Texas
United States	Eye Associates of New Mexico	Albuquerque	New Mexico
United States	Western Carolina Retinal Associate PA	Asheville	North Carolina
United States	Southeast Retina Center	Augusta	Georgia
United States	Retina Research Center	Austin	Texas
United States	Elman Retina Group	Baltimore	Maryland
United States	Retina Assoc of Cleveland Inc	Beachwood	Ohio
United States	Retina-Vitreous Assoc Med Grp	Beverly Hills	California
United States	Retina Group of Florida	Boca Raton	Florida
United States	Ophthalmic Consultants of Boston	Boston	Massachusetts
United States	Retinal Diagnostic Center	Campbell	California
United States	Char Eye Ear &Throat Assoc	Charlotte	North Carolina
United States	Cincinnati Eye Institute	Cincinnati	Ohio
United States	Texas Retina Associates	Dallas	Texas
United States	Vitreoretinal Surgery	Edina	Minnesota
United States	The Retina Partners	Encino	California
United States	National Ophthalmic Research Institute	Fort Myers	Florida
United States	Colorado Retina Associates, PC	Golden	Colorado
United States	Southeastern Retina Associates	Knoxville	Tennessee
United States	Charleston Neuroscience Institute	Ladson	South Carolina
United States	Loma Linda University	Loma Linda	California
United States	Opthalmic Consultants of LI	Lynbrook	New York
United States	Florida Eye Associates	Melbourne	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Tennessee Retina PC	Nashville	Tennessee
United States	Wagner Macula & Retina Center	Norfolk	Virginia
United States	San Diego Retina Associates	Oceanside	California
United States	Dean McGee Eye Institute	Oklahoma City	Oklahoma
United States	Retina Care Specialists	Palm Beach Gardens	Florida
United States	Retina Specialty Institute	Pensacola	Florida
United States	Mid Atlantic Retina	Philadelphia	Pennsylvania
United States	Retina Northwest	Portland	Oregon
United States	Sierra Eye Associates	Reno	Nevada
United States	The Retina Institute	Saint Louis	Missouri
United States	W Coast Retina Med Group Inc	San Francisco	California
United States	West Coast Retina	San Francisco	California
United States	California Retina Consultants	Santa Barbara	California
United States	Retina Macula Institute	Torrance	California
United States	Retina Centers P.C.	Tucson	Arizona
United States	Wolfe Eye Clinic	West Des Moines	Iowa
United States	Ctr for Retina & Macular Dis	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Ocular and Non-ocular Adverse Events (AEs)	An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are events localized to the eye. Non-ocular events include all other events.	From Day 1 up to the last study visit (up to approximately 62 months)