AzTrials
AzTrials

Geographic AtrophyPhase 2NCT02288559

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

A Phase 2 study testing Lampalizumab in people with Geographic Atrophy, run by Genentech, Inc. at 36 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Geographic Atrophy
What is being tested?
Lampalizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
96 participants
Where
36 sitesUnited States
Study dates
30 Mar 2015to 2 Jun 2017
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Complement Factor I (CFI) profile biomarker-positive result
  • Women of child bearing potential and men should remain abstinent or use contraceptive methods

Who cannot join

  • 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
Show all 23Show fewer
  • 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

Trial locations and contacts

36 sites in 1 country.

36 sites in 1 country

United States36 sites

  • W Texas Retina Consultants PA

    Abilene, Texas, 79606

  • Eye Associates of New Mexico

    Albuquerque, New Mexico, 87102

  • Western Carolina Retinal Associate PA

    Asheville, North Carolina, 28803

  • Elman Retina Group

    Baltimore, Maryland, 21237

  • Florida Eye Microsurgical Inst

    Boynton Beach, Florida, 33426

  • Retinal Diagnostic Center

    Campbell, California, 95008

  • Retina Cons of Charleston

    Charleston, South Carolina, 29414

  • Char Eye Ear &Throat Assoc

    Charlotte, North Carolina, 28210

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Cincinnati Eye Institute

    Cincinnati, Ohio, 45242

  • Retina Assoc of Cleveland Inc

    Cleveland, Ohio, 44122

  • Carolina Retina Center PA

    Columbia, South Carolina, 29223

  • Texas Retina Associates

    Dallas, Texas, 75231

  • Retina Specialists

    DeSoto, Texas, 75115

  • Vitreoretinal Surgery

    Edina, Minnesota, 55435

  • The Retina Partners

    Encino, California, 91436

  • National Ophthalmic Research Institute

    Fort Myers, Florida, 33912

  • Charles Retina Institution

    Germantown, Tennessee, 38138

  • Colorado Retina Associates, PC

    Golden, Colorado, 80401

  • Southeastern Retina Associates

    Knoxville, Tennessee, 37923

  • Loma Linda University

    Loma Linda, California, 92354

  • Florida Eye Associates

    Melbourne, Florida, 32901

  • Barnet Dulaney Perkins Eye Center

    Mesa, Arizona, 85206

  • Tennessee Retina PC.

    Nashville, Tennessee, 37203

  • Wagner Macula & Retina Center

    Norfolk, Virginia, 23451

  • San Diego Retina Associates

    Oceanside, California, 92056

  • Dean McGee Eye Institute

    Oklahoma City, Oklahoma, 73099

  • Retina Care Specialists

    Palm Beach Gardens, Florida, 33410

  • Retina Specialty Institute

    Pensacola, Florida, 32503

  • Sierra Eye Associates

    Reno, Nevada, 89502

  • West Coast Retina Medical Group

    San Francisco, California, 94109

  • California Retina Consultants

    Santa Barbara, California, 93103

  • Northwest Arkansas Retina Associates

    Springdale, Arkansas, 72764

  • The Retina Institute

    St Louis, Missouri, 63128

  • University of Arizona; Banner University Medical, Department of Opthalmology

    Tucson, Arizona, 85711

  • Wolfe Eye Clinic

    West Des Moines, Iowa, 50266

Other trials in United States

About this study

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

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.

Being tested
Sham, Lampalizumab
Medical subject headings
Geographic Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ShamOther

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

  • LampalizumabDrug

    10 mg dose of lampalizumab administered intravitreally

Study groups in NCT02288559
Study groupRoleWhat they receive
Lampalizumab: Open-label Safety Run-InExperimentalParticipants will receive 10 milligrams (mg) lampalizumab intravitreally Q2W during the safety run-in period.
Receives: Drug: Lampalizumab
Q2W Lampalizumab: Randomized TreatmentExperimentalParticipants will receive 10 mg dose of lampalizumab intravitreally Q2W during the 24-week treatment period.
Receives: Drug: Lampalizumab
Q4W Lampalizumab: Randomized TreatmentExperimentalParticipants will receive 10 mg dose of lampalizumab intravitreally Q4W during the 24-week treatment period.
Receives: Drug: Lampalizumab
Sham: Randomized TreatmentSham comparatorParticipants randomized to control arms will receive sham injections, that mimics intravitreal injection of lampalizumab.
Receives: Other: Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, Week 24

Secondary outcomes (5)

  1. 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)).

    Measured: Baseline (Day 1, predose and postdose), Weeks 2,4,8,16 and 24, early termination, unscheduled predose and postdose

  2. 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).

    Measured: Baseline (Day 1, predose and postdose), Weeks 4,8,16 and 24, early termination

  3. 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.

    Measured: Baseline up to approximately 30 weeks

  4. 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.

    Measured: Baseline up to approximately 30 weeks

  5. 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.

    Measured: Baseline up to approximately 30 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2014 (estimated)
  2. Study start30 Mar 2015
  3. Primary completion2 Jun 2017
  4. Study completion2 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02288559
Sponsor's protocol ID
GX29455
Status last verified
Sep 2019
First submitted
7 Nov 2014
Last updated
25 Sep 2019
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lampalizumab in people with Geographic Atrophy, run by Genentech, Inc. at 36 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Geographic Atrophy (GA) Area, as Assessed by Fundus Autofluorescence (FAF) at Week 24 (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02288559.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in