A Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Participants With Geographic Atrophy

Geographic Atrophy Clinical Trial

Official title:

A Phase II, Multicenter, Randomized, Single-Masked, Sham Injection-Controlled Exposure-Response Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Patients With Geographic Atrophy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02288559
• Other study ID #: GX29455
• Status: Completed
• Phase: Phase 2
• Start date: March 30, 2015
• Est. completion date: June 2, 2017

Study information

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

Clinical Trial Summary

This multicenter, randomized, single-masked, sham injection-controlled study will investigate the exposure-response and safety of lampalizumab administered intravitreally every 2 weeks (Q2W) or every 4 weeks (Q4W) for 24 weeks in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). A safety run-in assessment will be conducted prior to initiating enrollment in the randomized study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: June 2, 2017
• Est. primary completion date: June 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Complement Factor I (CFI) profile biomarker-positive result

• Women of child bearing potential and men should remain abstinent or use contraceptive methods

Exclusion Criteria:

• History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in study eye

• Previous subfoveal focal laser photocoagulation in study eye

• Laser photocoagulation in the study eye

• Prior treatment with external-beam radiation therapy or transpupillary thermotherapy in study eye

• Previous intravitreal drug administration in study eye. A single intraoperative administration of a corticosteroid during cataract surgery at least 3 months prior to screening is permitted

• Previous cell-based intraocular treatment in study eye

• Intraocular surgery in study eye

• Uncontrolled glaucoma and history of glaucoma-filtering surgery in study eye

• History of corneal transplant in study eye

• GA in either eye due to causes other than AMD

• Proliferative diabetic retinopathy in either eye

• Active or history of neovascular (wet) AMD in either eye

• History of idiopathic or autoimmune-associated uveitis, ocular or intraocular conditions, and infectious or inflammatory ocular disease

• Active uveitis and infectious conjunctivitis, keratitis, scleritis or endophthalmitis

• Previous systemic treatment with complement inhibitor and with inhibitors/modulators of visual cycle

• Previous expression vector mediated intraocular treatments

• Uncontrolled blood pressure and atrial fibrillation

• Medical conditions associated with clinically significant risk for bleeding-

• Predisposition or history of increased risk for infection

• Active malignancy within the previous 12 months except for appropriately treated carcinoma in situ of cervix, resolved non-melanoma skin carcinoma, and prostate cancer with a Gleason score of less than or equal to 6, and a stable prostate-specific antigen for greater than or equal to (>/=) 12 months

• History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of lampalizumab injection

• Women of child bearing potential must have a negative serum pregnancy test within 28 days prior to initiation of study treatment

• Previous participation in other studies of investigational drugs

Related Conditions & MeSH terms

• Atrophy
• Geographic Atrophy

Intervention

Other:
• Sham
Sham injection will be administered as a matching intravitreal injection of lampalizumab.

Drug:
• Lampalizumab
10 mg dose of lampalizumab administered intravitreally

Locations

Country	Name	City	State
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	Elman Retina Group	Baltimore	Maryland
United States	Florida Eye Microsurgical Inst	Boynton Beach	Florida
United States	Retinal Diagnostic Center	Campbell	California
United States	Retina Cons of Charleston	Charleston	South Carolina
United States	Char Eye Ear &Throat Assoc	Charlotte	North Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	Cincinnati Eye Institute	Cincinnati	Ohio
United States	Retina Assoc of Cleveland Inc	Cleveland	Ohio
United States	Carolina Retina Center PA	Columbia	South Carolina
United States	Texas Retina Associates	Dallas	Texas
United States	Retina Specialists	DeSoto	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	Charles Retina Institution	Germantown	Tennessee
United States	Colorado Retina Associates, PC	Golden	Colorado
United States	Southeastern Retina Associates	Knoxville	Tennessee
United States	Loma Linda University	Loma Linda	California
United States	Florida Eye Associates	Melbourne	Florida
United States	Barnet Dulaney Perkins Eye Center	Mesa	Arizona
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	Sierra Eye Associates	Reno	Nevada
United States	The Retina Institute	Saint Louis	Missouri
United States	West Coast Retina Medical Group	San Francisco	California
United States	California Retina Consultants	Santa Barbara	California
United States	Northwest Arkansas Retina Associates	Springdale	Arkansas
United States	University of Arizona; Banner University Medical, Department of Opthalmology	Tucson	Arizona
United States	Wolfe Eye Clinic	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Geographic Atrophy (GA) Area, as Assessed by Fundus Autofluorescence (FAF) at Week 24	GA or the death of photoreceptors and surrounding cells in the retina, is a common condition in participants with age-related macular degeneration (AMD). The death of these photoreceptors results in lesions that cause vision loss. 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 geographic atrophy lesion area (worsening; disease progression). BCVA=best corrected visual acuity; ETDRS=Early Treatment Diabetic Retinopathy Scale.	Baseline, Week 24
Secondary	Serum Concentrations of Lampalizumab (Q2W)	Lower than reportable (LTR) results on pre-dose sample were set to 0, and LTR results on post-dose sample were set to half of lower limit of quantification (LLOQ) (0.5 nanograms per milliliter (ng/mL)).	Baseline (Day 1, predose and postdose), Weeks 2,4,8,16 and 24, early termination, unscheduled predose and postdose
Secondary	Serum Concentrations of Lampalizumab (Q4W)	LTR results on pre-dose sample were set to 0, and LTR results on post-dose sample were set to half of LLOQ (0.5 ng/mL).	Baseline (Day 1, predose and postdose), Weeks 4,8,16 and 24, early termination
Secondary	Percentage of Participants With 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 the events which are localized in the ocular region.	Baseline up to approximately 30 weeks
Secondary	Percentage of Participants With Systemic (Non-ocular) Adverse Events	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. Non-ocular AEs were the systemic events.	Baseline up to approximately 30 weeks
Secondary	Percentage of Participants With Anti-Lampalizumab Antibodies	Having treatment-induced anti-drug antibodies (ADAs) was defined as being ADA-negative at baseline and ADA-positive at any post-baseline timepoint. Having treatment-enhanced ADAs was defined as being ADA-positive at baseline with titer values increased by 0.6 titer units at any post-baseline timepoint.	Baseline up to approximately 30 weeks