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Geographic AtrophyPhase 2NCT01229215

A Study of Safety, Tolerability, and Evidence of Activity of FCFD4514S Administered Monthly or Every Other Month to Patients With Geographic Atrophy

A Phase 2 study testing FCFD4514S in people with Geographic Atrophy, run by Genentech, Inc. at 36 sites in 2 countries.

Completed

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

Official record
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Trial summary

This is a Phase Ib/II, multicenter, randomized, single-masked, sham-injection-controlled study of safety, tolerability, and evidence of activity of FCFD4514S intravitreal injections administered monthly or every other month in patients with geographic atrophy. Read more about this study

Who is it for?
Ages 60 to 89 years
Conditions the study is for
Geographic Atrophy
What is being tested?
FCFD4514S
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
143 participants
Where
36 sitesin 2 countries
Study dates
Feb 2011to Apr 2013
Phase
Phase 2
Are there results?
None posted in the registry

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 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willingness and ability to provide signed Informed Consent; in addition, at U.S. sites, Health Insurance Portability and Accountability Act (HIPAA) authorization, in other countries, as applicable according to national laws
  • Well-demarcated area of GA secondary to age-related macular degeneration (AMD) in the absence of choroidal neovascularization (CNV)

Who cannot join

  • History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
  • Previous subfoveal focal laser photocoagulation in the study eye
  • Laser photocoagulation in the study eye
  • Prior treatment with Visudyne, external-beam radiation therapy, or transpupillary thermotherapy in the study eye
  • GA in either eye due to causes other than AMD
  • Diabetic retinopathy in either eye
Show all 10Show fewer
  • Active or history of wet AMD in either eye
  • History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or that renders the patient at high risk for treatment complications
  • Active malignancy or history of malignancy within the past 5 years
  • Previous participation in any studies of investigational drugs within 3 months preceding Day 0

Trial locations and contacts

36 sites in 2 countries.

36 sites in 2 countries

United States30 sites

  • Study site

    Abilene, Texas, 79606

  • Study site

    Augusta, Georgia, 30909

  • Study site

    Austin, Texas, 78705

  • Study site

    Baltimore, Maryland, 21287

  • Study site

    Beachwood, Ohio, 44122

  • Study site

    Beverly Hills, California, 90211

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Boynton Beach, Florida, 33426

  • Study site

    Charlotte, North Carolina, 28210

  • Study site

    Cincinnati, Ohio, 45242

  • Study site

    Dallas, Texas, 75231

  • Study site

    Edina, Minnesota, 55435

  • Study site

    Fort Lauderdale, Florida, 33334

  • Study site

    Lynbrook, New York, 11563

  • Study site

    Milwaukee, Wisconsin, 53226

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    New York, New York, 10003

  • Study site

    Paducah, Kentucky, 42001

  • Study site

    Palm Beach Gardens, Florida, 33410

  • Study site

    Pensacola, Florida, 32503

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Philadelphia, Pennsylvania, 19107

  • Study site

    Portland, Oregon, 97210

  • Study site

    Rochester, New York, 14642

  • Study site

    San Francisco, California, 94107

  • Study site

    Santa Barbara, California, 93103

  • Study site

    Torrance, California, 90503

  • Study site

    Tucson, Arizona, 85704

  • Study site

    West Columbia, South Carolina, 29169

  • Study site

    Winter Haven, Florida, 33880

Other trials in United States

Germany6 sites

  • Study site

    Bonn, 53127

  • Study site

    Freiburg im Breisgau, 79106

  • Study site

    Heidelberg, 69120

  • Study site

    Leipzig, 04103

  • Study site

    Münster, 48145

  • Study site

    Tübingen, 72076

Other trials in Germany

About this study

Official title: A Phase Ib/II, Multicenter, Randomized, Single-Masked, Sham Injection-Controlled Study of Safety, Tolerability, and Evidence of Activity of FCFD4514S Intravitreal Injections Administered Monthly or Every Other Month to Patients With Geographic Atrophy

This is a Phase Ib/II, multicenter, randomized, single-masked, sham-injection-controlled study of safety, tolerability, and evidence of activity of FCFD4514S intravitreal injections administered monthly or every other month in patients with geographic atrophy.

Being tested
FCFD4514S, sham
Medical subject headings
Geographic Atrophy

What participants receive

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

  • FCFD4514SDrug

    Repeating intravitreal injection

  • shamDrug

    Repeating sham injection

Study groups in NCT01229215
Study groupRoleWhat they receive
FCFD4514SExperimentalNot described
Receives: Drug: FCFD4514S
shamSham comparatorNot described
Receives: Drug: sham

What is being measured

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

  1. Growth rate of geographic atrophy (GA) lesion area from baseline

    Measured: Month 18

Secondary outcomes (1)

  1. Mean change in best corrected visual acuity (BCVA) from baseline

    Measured: Month 18

Timeline

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

  1. First posted27 Oct 2010 (estimated)
  2. Study startFeb 2011
  3. Primary completionApr 2013
  4. Study completionApr 2013

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
143 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01229215
Sponsor's protocol ID
CFD4870g
Other IDs
GX01456
Status last verified
Nov 2016
First submitted
25 Oct 2010
Last updated
2 Nov 2016
Results posted
No

Publications

  • Tzoumas N, Riding G, Williams MA, Steel DH. Complement inhibitors for age-related macular degeneration. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD009300. doi: 10.1002/14651858.CD009300.pub3.

    PubMed 37314061

  • Sivaprasad S, Tschosik E, Kapre A, Varma R, Bressler NM, Kimel M, Dolan C, Silverman D. Reliability and Construct Validity of the NEI VFQ-25 in a Subset of Patients With Geographic Atrophy From the Phase 2 Mahalo Study. Am J Ophthalmol. 2018 Jun;190:1-8. doi: 10.1016/j.ajo.2018.03.006. Epub 2018 Mar 10.

    PubMed 29530781

  • Kimel M, Leidy NK, Tschosik E, Dolan C, Souied EH, Varma R, Bressler NM. Functional Reading Independence (FRI) Index: A New Patient-Reported Outcome Measure for Patients With Geographic Atrophy. Invest Ophthalmol Vis Sci. 2016 Nov 1;57(14):6298-6304. doi: 10.1167/iovs.16-20361.

    PubMed 27893095

  • Hariri A, Nittala MG, Sadda SR. Outer retinal tubulation as a predictor of the enlargement amount of geographic atrophy in age-related macular degeneration. Ophthalmology. 2015 Feb;122(2):407-13. doi: 10.1016/j.ophtha.2014.08.035. Epub 2014 Oct 12.

    PubMed 25315664

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FCFD4514S in people with Geographic Atrophy, run by Genentech, Inc. at 36 sites in 2 countries.

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 10 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 2 Nov 2016. 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, Germany. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Growth rate of geographic atrophy (GA) lesion area from baseline (time frame: Month 18). 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 NCT01229215, which also lists 4 linked publications.

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 2 Nov 2016.

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