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Retinal Vein OcclusionPhase 3GALILEONCT01012973

Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO)

A Phase 3 study testing Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321) in people with Retinal Vein Occlusion, run by Bayer at 73 sites in 10 countries.

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

To determine the efficacy of vascular endothelial growth factor (VEGF) Trap-Eye injected into the eye on vision function in subjects with macular edema as a consequence of central retinal vein occlusion Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Retinal Vein Occlusion
What is being tested?
Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
177 participants
Where
73 sitesin 10 countries
Study dates
Oct 2009to Feb 2012
Phase
Phase 3
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Center-involved macular edema secondary to central retinal vein occlusion (CRVO) for no longer than 9 months with mean central subfield thickness ≥ 250 μm on optical coherence tomography (OCT)
  • Adults ≥ 18 years
  • Early treatment diabetic retinopathy study (ETDRS) best corrected visual acuity (BCVA) of 20/40 to 20/320 (73 to 24 letters) in the study eye

Who cannot join

  • Any prior treatment with anti-VEGF agents in the study eye (Pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc.) or previous administration of systemic anti-angiogenic medications
  • Prior panretinal laser photocoagulation or macular laser photocoagulation in the study eye
  • CRVO disease duration > 9 months from date of diagnosis
  • Previous use of intraocular corticosteroids in the study eye or use of periocular corticosteroids in the study eye within the 3 months prior to Day 1
  • Iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in either the study eye or fellow eye

Trial locations and contacts

73 sites in 10 countries.

73 sites in 10 countries

Germany25 sites

  • Study site

    Aachen, North Rhine-Westphalia, 52074

  • Study site

    Berlin, State of Berlin, 13353

  • Study site

    Bonn, North Rhine-Westphalia, 53105

  • Study site

    Chemnitz, Saxony, 09116

  • Study site

    Cologne, North Rhine-Westphalia, 50924

  • Study site

    Darmstadt, Hesse, 64297

  • Study site

    Dresden, Saxony, 01307

  • Study site

    Dresden, Saxony, 06067

  • Study site

    Essen, North Rhine-Westphalia, 45122

  • Study site

    Frankfurt am Main, Hesse, 60596

  • Study site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Study site

    Göttingen, Lower Saxony, 37075

  • Study site

    Hamburg, Free and Hanseatic City of Hamburg, 20251

  • Study site

    Heidelberg, Baden-Wurttemberg, 69120

  • Study site

    Homburg, Saarland, 66421

  • Study site

    Kiel, Schleswig-Holstein, 24105

  • Study site

    Leipzig, Saxony, 04103

  • Study site

    Lübeck, Schleswig-Holstein, 23538

  • Study site

    Ludwigshafen am Rhein, Rhineland-Palatinate, 67063

  • Study site

    Mainz, Rhineland-Palatinate, 55131

  • Study site

    Marburg, Hesse, 35037

  • Study site

    München, Bavaria, 81675

  • Study site

    Münster, North Rhine-Westphalia, 48145

  • Study site

    Regensburg, Bavaria, 93053

  • Study site

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Italy11 sites

  • Study site

    Ancona, 60126

  • Study site

    Bari, 70124

  • Study site

    Catania, 95123

  • Study site

    Florence, 50134

  • Study site

    Milan, 20122

  • Study site

    Milan, 20132

  • Study site

    Milan, 20157

  • Study site

    Padova, 35128

  • Study site

    Roma, 00133

  • Study site

    Roma, 00198

  • Study site

    Torino, 10122

Other trials in Italy

Australia6 sites

  • Study site

    Chatswood, New South Wales, 2067

  • Study site

    East Melbourne, Victoria, 3002

  • Study site

    Nedlands, Western Australia, 6009

  • Study site

    Parramatta, New South Wales, 2150

  • Study site

    Sydney, New South Wales, 2000

  • Study site

    Westmead, New South Wales, 2145

Other trials in Australia

France6 sites

  • Study site

    Bordeaux, 33000

  • Study site

    Dijon, 21033

  • Study site

    Marseille, 13008

  • Study site

    Nantes, Cedex 1, 44093

  • Study site

    Paris, Cedex 12, 75557

  • Study site

    Paris, 75015

Other trials in France

Hungary6 sites

  • Study site

    Budapest, 1089

  • Study site

    Budapest, 1106

  • Study site

    Budapest, 1133

  • Study site

    Debrecen, 4032

  • Study site

    Veszprém, 8200

  • Study site

    Zalaegerszeg, H-8900

Other trials in Hungary

Japan6 sites

  • Study site

    Chiyoda-ku, Tokyo, 101-8309

  • Study site

    Kyoto, Kyoto, 606-8507

  • Study site

    Nagoya, Aichi-ken, 466-8560

  • Study site

    Nagoya, Aichi-ken, 467-8602

  • Study site

    Suita, Osaka, 565-0871

  • Study site

    Urayasu, Chiba, 279-0021

Other trials in Japan

South Korea6 sites

  • Study site

    Incheon, 405-760

  • Study site

    Seongnam-si, Gyeonggido, 463-707

  • Study site

    Seoul, 110 744

  • Study site

    Seoul, 137-701

  • Study site

    Seoul, 138-736

  • Study site

    Seoul

Other trials in South Korea

Austria3 sites

  • Study site

    Innsbruck, 6020

  • Study site

    Linz, 4021

  • Study site

    Vienna, 1090

Other trials in Austria

Latvia2 sites

  • Study site

    Riga, 1002

  • Study site

    Riga, 1050

Other trials in Latvia

Singapore2 sites

  • Study site

    Singapore, 119074

  • Study site

    Singapore, 168751

Other trials in Singapore

About this study

Official title: A Randomized, Double-masked, Sham-controlled Phase 3 Study of the Efficacy, Safety and Tolerability of Repeated Intravitreal Administration of VEGF Trap-Eye in Subjects With Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)

To determine the efficacy of vascular endothelial growth factor (VEGF) Trap-Eye injected into the eye on vision function in subjects with macular edema as a consequence of central retinal vein occlusion

Being tested
Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321), Sham treatment
Keywords
Macular Edema, Central Retinal Vein Occlusion, CRVO, VEGF Trap-Eye, best-corrected visual acuity
Medical subject headings
Retinal Vein Occlusion, Macular Edema

What participants receive

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

  • Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)Biological

    Intravitreal injection. Weeks 0 to 20 of Aflibercept Injection every 4 weeks; Weeks 24 to 52 every 4 weeks PRN (pro re nata, on demand); plus additional on Week 60 and 68.

  • Sham treatmentOther

    Sham treatment. Weeks 0 to 52 sham treatment every 4 weeks; plus additional on Week 60 and 68.

Study groups in NCT01012973
Study groupRoleWhat they receive
Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)ExperimentalParticipants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
Receives: Biological: Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321); Other: Sham treatment
Sham treatmentSham comparatorParticipants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
Receives: Other: Sham treatment

What is being measured

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

  1. Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 24 With Discontinued Participants Before Week 24 Evaluated as Failures

    Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.

    Measured: Baseline and Week 24

Secondary outcomes (5)

  1. Change From Baseline in BCVA as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 24 - Last Observation Carried Forward (LOCF)

    Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning. However, because this was assessed at the screening visit, subjects may have had a higher BCVA recorded at the baseline visit and would not have been excluded from the study.

    Measured: Baseline and Week 24

  2. Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF

    Measured: Baseline and Week 24

  3. Percentage of Participants Who Developed Neovascularization During the First 24 Weeks

    Formation of blood vessels in the anterior segment, optic disc, or elsewhere in the fundus up to Week 24

    Measured: From baseline until Week 24

  4. Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score at Week 24 - LOCF

    The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight

    Measured: Baseline and Week 24

  5. Change From Baseline in European Five-dimensional Health Scale (EQ-5D) Score at Week 24 - LOCF

    EQ-5D is a quality of life questionnaire based on a scale from -0.594 (worst) to 1.00 (best).

    Measured: Baseline and Week 24

Timeline

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

  1. First posted13 Nov 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionFeb 2011
  4. Study completionFeb 2012

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
177 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01012973
Sponsor's protocol ID
14130
Other IDs
2009-010973-19, 2009
Acronym
GALILEO
Status last verified
Oct 2014
First submitted
30 Oct 2009
Last updated
3 Nov 2014
Data monitoring committee
Yes

Publications

  • Holz FG, Roider J, Ogura Y, Korobelnik JF, Simader C, Groetzbach G, Vitti R, Berliner AJ, Hiemeyer F, Beckmann K, Zeitz O, Sandbrink R. VEGF Trap-Eye for macular oedema secondary to central retinal vein occlusion: 6-month results of the phase III GALILEO study. Br J Ophthalmol. 2013 Mar;97(3):278-84. doi: 10.1136/bjophthalmol-2012-301504. Epub 2013 Jan 7.

    PubMed 23298885

  • Korobelnik JF, Holz FG, Roider J, Ogura Y, Simader C, Schmidt-Erfurth U, Lorenz K, Honda M, Vitti R, Berliner AJ, Hiemeyer F, Stemper B, Zeitz O, Sandbrink R; GALILEO Study Group. Intravitreal Aflibercept Injection for Macular Edema Resulting from Central Retinal Vein Occlusion: One-Year Results of the Phase 3 GALILEO Study. Ophthalmology. 2014 Jan;121(1):202-208. doi: 10.1016/j.ophtha.2013.08.012. Epub 2013 Sep 29.

    PubMed 24084497

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321) in people with Retinal Vein Occlusion, run by Bayer at 73 sites in 10 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 3 inclusion and 5 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 3 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in Germany, Italy, Australia, France, Hungary and 5 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 22 Nov 2012). 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?

Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 24 With Discontinued Participants Before Week 24 Evaluated as Failures (time frame: Baseline and 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 NCT01012973, which also lists 2 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 3 Nov 2014.

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