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Macular DegenerationPhase 3VIEW 2NCT00637377

Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD)

A Phase 3 study testing Ranibizumab and Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321) in people with Macular Degeneration, run by Bayer at 189 sites in 26 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

This study is a phase III, double-masked, randomized, study of the efficacy and safety of VEGF Trap-Eye in patients with neovascular age-related macular degeneration. Approximately 1200 patients will be randomized in Europe, Asia, Japan, Australia and South America. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Macular Degeneration
What is being tested?
Ranibizumab and Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,240 participants
Where
189 sitesin 26 countries
Study dates
Apr 2008to Aug 2011
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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent.
  • Men and women >/=50 years of age.
  • Active primary or recurrent subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by Fluorescein angiography (FA) in the study eye.
  • ETDRS Best-Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye at 4 meters.
  • Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.
  • Able to read, (or, if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member) understand and willing to sign the informed consent form.

Who cannot join

  • Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD, except dietary supplements or vitamins.
  • Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye.
  • Any prior treatment with anti-VEGF agents in the study eye.
  • Total lesion size >12 disc areas (30.5 mm, including blood, scars and neovascularization) as assessed by FA in the study eye.
  • Subretinal hemorrhages that is either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye (if the blood is under the fovea, then the fovea must be surrounded by 270 degrees by visible CNV).
  • Scar or fibrosis making up >50% of the total lesion in the study eye.
Show all 15Show fewer
  • Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
  • Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
  • History of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye.
  • Presence of other causes of CNV in the study eye.
  • Prior vitrectomy in the study eye.
  • History of retinal detachment or treatment or surgery for retinal detachment in the study eye.
  • Any history of macular hole of stage 2 and above in the study eye.
  • Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of Day 1, as long as it is unlikely to interfere with the injection.
  • History or clinical evidence of diabetic retinopathy, diabetic macular edema or any retinal vascular disease other than AMD in either eye.

Trial locations and contacts

189 sites in 26 countries.

189 sites in 26 countries

Germany21 sites

  • Study site

    Aachen, North Rhine-Westphalia, 52074

  • Study site

    Berlin, State of Berlin, 12200

  • Study site

    Bonn, North Rhine-Westphalia, 53105

  • 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

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • 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

    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

Spain16 sites

  • Study site

    Alicante, Alicante, 03016

  • Study site

    Barcelona, 08017

  • Study site

    Barcelona, 08022

  • Study site

    Barcelona, 08035

  • Study site

    Barcelona, 08036

  • Study site

    Madrid, Madrid, 28002

  • Study site

    Madrid, 28046

  • Study site

    Málaga, 29010

  • Study site

    Oviedo, Principality of Asturias, 33012

  • Study site

    Pamplona, Navarre, 31008

  • Study site

    Santiago de Compostela, A Coruña, 15705

  • Study site

    Seville, 41009

  • Study site

    Seville, 41013

  • Study site

    Valencia, 46014

  • Study site

    Valencia, 46015

  • Study site

    Valladolid, 47005

Other trials in Spain

India15 sites

  • Study site

    Ahemedabad - 4, Gujarat, 380009

  • Study site

    Bangalore, 560010

  • Study site

    Chandigarh, 160012

  • Study site

    Chennai, Tamil Nadu, 600 006

  • Study site

    Coimbatore, Tamil Nadu, 641014

  • Study site

    Hyderabad, 500 034

  • Study site

    Kerala, 683572

  • Study site

    Kolkata, 700073

  • Study site

    Madurai, Tamil Nadu, 625 020

  • Study site

    Mumbai, 400 050

  • Study site

    New Delhi, 110002

  • Study site

    New Delhi, 110029

  • Study site

    Orissa, 751 024

  • Study site

    Pondicherry, Tamil Nadu, 600007

  • Study site

    Wadala, Mumbai, Maharashtra, 400031

Other trials in India

Italy15 sites

  • Study site

    Ancona, 60126

  • Study site

    Bari, 70124

  • Study site

    Catania, 95123

  • Study site

    Genova, 16132

  • Study site

    Milan, 20122

  • Study site

    Milan, 20132

  • Study site

    Milan, 20157

  • Study site

    Padova, 35128

  • Study site

    Roma, 00133

  • Study site

    Roma, 00168

  • Study site

    Roma, 00198

  • Study site

    Torino, 10122

  • Study site

    Udine, 33100

  • Study site

    Varese, 21100

  • Study site

    Verona, 37121

Other trials in Italy

Japan15 sites

  • Study site

    Chiyoda-ku, Tokyo, 101-8309

  • Study site

    Fukuoka, Fukuoka, 812-8582

  • Study site

    Fukushima, Fukushima, 960-1295

  • Study site

    Hirakata, Osaka, 573-1191

  • Study site

    Kagoshima, Kagoshima-ken, 890-8520

  • Study site

    Kita, Kagawa-ken, 761-0793

  • Study site

    Kyoto, Kyoto, 606-8507

  • Study site

    Maebashi, Gunma, 371-8511

  • Study site

    Nagoya, Aichi-ken, 466-8560

  • Study site

    Nagoya, Aichi-ken, 467-8602

  • Study site

    Ōtsu, Shiga, 520-2192

  • Study site

    Sapporo, Hokkaido, 060-8604

  • Study site

    Shinjuku-ku, Tokyo, 160-8582

  • Study site

    Suita, Osaka, 565-0871

  • Study site

    Urayasu, Chiba, 279-0021

Other trials in Japan

France10 sites

  • Study site

    Besançon, 25030

  • Study site

    Bordeaux, 33000

  • Study site

    Dijon, 21079

  • Study site

    Lyon, 69003

  • Study site

    Lyon, 69006

  • Study site

    Marseille, 13008

  • Study site

    Nantes, Cedex 1, 44093

  • Study site

    Paris, Cedex 12, 75557

  • Study site

    Paris, 75010

  • Study site

    Paris, 75015

Other trials in France

Israel10 sites

  • Study site

    Afula

  • Study site

    Beersheba

  • Study site

    Haifa, Israel, 34362

  • Study site

    Jerusalem, 91120

  • Study site

    Kfar Saba, Israel

  • Study site

    Petah Tikva, Israel, 49100

  • Study site

    Rehovot, 76100

  • Study site

    Tel Aviv, 64239

  • Study site

    Tel HaShomer

  • Study site

    Zrifin, Israel, 70300

Other trials in Israel

United Kingdom10 sites

  • Study site

    Aberdeen, AB25 2ZN

  • Study site

    Belfast, BT12 6BA

  • Study site

    Birmingham, B4 7ET

  • Study site

    Camberley, Surrey, GU16 5UJ

  • Study site

    Liverpool, L7 8XP

  • Study site

    London, NW1 5QH

  • Study site

    London, SE5 9RS

  • Study site

    Plymouth, PL4 6PL

  • Study site

    Southampton, Hampshire, SO16 6YD

  • Study site

    Torquay, TQ2 7AA

Other trials in United Kingdom

Mexico8 sites

  • Study site

    Chihuahua City, Chihuahua, 31238

  • Study site

    Metepec, State of Mexico, 52140

  • Study site

    Mexico City, Mexico City, 06800

  • Study site

    Mexico City, 06030

  • Study site

    México D.F., 04030

  • Study site

    Monterrey, Nuevo León, 64060

  • Study site

    Monterrey, Nuevo León, 64480

  • Study site

    Zapopan, Jalisco, 45060

Other trials in Mexico

Australia7 sites

  • Study site

    Chatswood, New South Wales, 2067

  • Study site

    East Melbourne, Victoria, 3002

  • Study site

    Nedlands, Western Australia, 6009

  • Study site

    Parkville, Victoria, 3050

  • Study site

    Parramatta, 2150

  • Study site

    Sydney, New South Wales, 2000

  • Study site

    Westmead, New South Wales, 2145

Other trials in Australia

Poland7 sites

  • Study site

    Bydgoszcz, 85-631

  • Study site

    Gdansk, 80-952

  • Study site

    Katowice, 40-760

  • Study site

    Poznan, 61-848

  • Study site

    Warsaw, 00-416

  • Study site

    Warszaa, 02-005

  • Study site

    Wroclaw, 50-368

Other trials in Poland

Argentina6 sites

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1015ABO

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1023AAQ

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1122AAI

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1181ACH

  • Study site

    Córdoba, Córdoba Province, X5000IIT

  • Study site

    Rosario, Santa Fe Province, S2000ANJ

Other trials in Argentina

South Korea6 sites

  • Study site

    Incheon, 405-760

  • Study site

    Seongnam, Gyeonggido, 463 707

  • Study site

    Seoul, 110 744

  • Study site

    Seoul, 137 701

  • Study site

    Seoul, 138-736

  • Study site

    Seoul, 152-703

Other trials in South Korea

Czechia5 sites

  • Study site

    Brno, 63400

  • Study site

    Olomouc, 77520

  • Study site

    Prague, 10034

  • Study site

    Prague, 14000

  • Study site

    Ústí nad Labem, 401 13

Other trials in Czechia

Netherlands5 sites

  • Study site

    Amsterdam, 1100 DD

  • Study site

    Groningen, 9713 GZ

  • Study site

    Leiden, ZA, 2333

  • Study site

    Nijmegen, 6525 EX

  • Study site

    Rotterdam, 3000 CA

Other trials in Netherlands

Brazil4 sites

  • Study site

    Minas Gerais, 30150-270

  • Study site

    Ribeirão Preto, São Paulo, 14048-900

  • Study site

    São Paulo, São Paulo, 04023-062

  • Study site

    São Paulo, São Paulo, 05651-901

Other trials in Brazil

Hungary4 sites

  • Study site

    Budapest, 1083

  • Study site

    Budapest, 1106

  • Study site

    Budapest, 1133

  • Study site

    Veszprém, 8200

Other trials in Hungary

Singapore4 sites

  • Study site

    Singapore, 119074

  • Study site

    Singapore, 159964

  • Study site

    Singapore, 168751

  • Study site

    Singapore, 308433

Other trials in Singapore

Switzerland4 sites

  • Study site

    Basel, 4031

  • Study site

    Bern, 3010

  • Study site

    Geneva, 1211

  • Study site

    Zurich, 8091

Other trials in Switzerland

Austria3 sites

  • Study site

    Innsbruck, 6020

  • Study site

    Linz, 4021

  • Study site

    Vienna, 1090

Other trials in Austria

Colombia3 sites

  • Study site

    Bogotá, Bogota D.C.

  • Study site

    Cali, Cauca Department

  • Study site

    Medellín, Antioquia

Other trials in Colombia

Latvia3 sites

  • Study site

    Riga, 1002

  • Study site

    Riga, 1009

  • Study site

    Riga, 1050

Other trials in Latvia

Sweden3 sites

  • Study site

    Linköping, 58185

  • Study site

    Örebro, 70185

  • Study site

    Stockholm, 11282

Other trials in Sweden

Portugal2 sites

  • Study site

    Coimbra, 3000-548

  • Study site

    Porto, 4200-319

Other trials in Portugal

Slovakia2 sites

  • Study site

    Banská Bystrica, 97517

  • Study site

    Bratislava, 81369

Other trials in Slovakia

Belgium1 site

  • Study site

    Liège, 4000

Other trials in Belgium

About this study

Official title: A Randomized, Double Masked, Active Controlled, Phase 3 Study of the Efficacy, Safety, and Tolerability of Repeated Doses of Intravitreal VEGF Trap in Subjects With Neovascular Age-related Macular Degeneration (AMD)

This study is a phase III, double-masked, randomized, study of the efficacy and safety of VEGF Trap-Eye in patients with neovascular age-related macular degeneration. Approximately 1200 patients will be randomized in Europe, Asia, Japan, Australia and South America.

Read the detailed description

Data of this trial ("VIEW 2") was pooled with data of a sister trial ("VIEW 1", NCT00509795), and an integrated analyses of the combined data was performed.

Being tested
Ranibizumab, Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
Keywords
Eye diseases, Vision Impairment and Blindness, Eyes and Vision, Seniors, Neovascular Age-Related Macular Degeneration (AMD), Retinal Disease
Medical subject headings
Macular Degeneration, Eye Diseases, Vision Disorders, Blindness, Retinal Diseases

What participants receive

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

  • RanibizumabDrug

    Participants received a 0.5 mg dose of Ranibizumab via intravitreal (IVT) injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.

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

    Participants received a 2.0 mg dose of Aflibercept Injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.

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

    Participants received a 0.5 mg dose of Aflibercept Injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.

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

    Participants received a 2.0 mg dose of Aflibercept Injection administered every 8 weeks (including one additional 2,0 mg dose at Week 4) for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.

Study groups in NCT00637377
Study groupRoleWhat they receive
Ranibizumab 0.5mg Q4Active comparatorParticipants received a 0.5 mg dose of Ranibizumab via intravitreal (IVT) injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
Receives: Drug: Ranibizumab
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4ExperimentalParticipants received a 2.0 mg dose of Aflibercept Injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
Receives: Biological: Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4ExperimentalParticipants received a 0.5 mg dose of Aflibercept Injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
Receives: Biological: Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8ExperimentalParticipants received a 2.0 mg dose of Aflibercept Injection administered every 8 weeks (including one additional 2,0 mg dose at Week 4) for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
Receives: Biological: Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)

What is being measured

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

  1. Percentage of Participants Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF)

    Maintenance of vision was defined as a loss of < 15 letters in the ETDRS (Early Treatment Diabetic Retinopathy Study) letter score (defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 25 (= 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: At week 52

Secondary outcomes (4)

  1. Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Letter Score at Week 52 - LOCF

    Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.

    Measured: Baseline and at week 52

  2. Percentage of Participants Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 - LOCF

    Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 25 (= 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: At week 52

  3. Mean Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score at Week 52 - LOCF

    The possible range of the NEI VFQ-25 total score is between 0 (worst possible) and 100 (best possible).

    Measured: Baseline and at week 52

  4. Mean Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 52 - LOCF

    CNV area values measured in square millimeters; lower values represent better outcomes.

    Measured: Baseline and at week 52

Timeline

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

  1. First posted18 Mar 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionSep 2010
  4. Study completionAug 2011

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00637377
Sponsor's protocol ID
91689
Other IDs
2007-000583-25
Acronym
VIEW 2
Status last verified
Nov 2014
First submitted
12 Mar 2008
Last updated
12 Dec 2014
Data monitoring committee
Yes

Publications

  • Heier JS, Brown DM, Chong V, Korobelnik JF, Kaiser PK, Nguyen QD, Kirchhof B, Ho A, Ogura Y, Yancopoulos GD, Stahl N, Vitti R, Berliner AJ, Soo Y, Anderesi M, Groetzbach G, Sommerauer B, Sandbrink R, Simader C, Schmidt-Erfurth U; VIEW 1 and VIEW 2 Study Groups. Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration. Ophthalmology. 2012 Dec;119(12):2537-48. doi: 10.1016/j.ophtha.2012.09.006. Epub 2012 Oct 17.

    PubMed 23084240

  • Schmidt-Erfurth U, Kaiser PK, Korobelnik JF, Brown DM, Chong V, Nguyen QD, Ho AC, Ogura Y, Simader C, Jaffe GJ, Slakter JS, Yancopoulos GD, Stahl N, Vitti R, Berliner AJ, Soo Y, Anderesi M, Sowade O, Zeitz O, Norenberg C, Sandbrink R, Heier JS. Intravitreal aflibercept injection for neovascular age-related macular degeneration: ninety-six-week results of the VIEW studies. Ophthalmology. 2014 Jan;121(1):193-201. doi: 10.1016/j.ophtha.2013.08.011. Epub 2013 Sep 29.

    PubMed 24084500

  • Lukacs R, Schneider M, Nagy ZZ, Sandor GL, Kaan K, Asztalos A, Enyedi L, Pek G, Barcsay G, Szabo A, Borbandy A, Kovacs I, Resch MD, Papp A. Seven-year outcomes following intensive anti-vascular endothelial growth factor therapy in patients with exudative age-related macular degeneration. BMC Ophthalmol. 2023 Mar 17;23(1):110. doi: 10.1186/s12886-023-02843-2.

    PubMed 36932356

  • Moshfeghi DM, Thompson D, Saroj N. Changes in neovascular activity following fixed dosing with an anti-vascular endothelial growth factor agent over 52 weeks in the phase III VIEW 1 and VIEW 2 studies. Br J Ophthalmol. 2020 Sep;104(9):1223-1227. doi: 10.1136/bjophthalmol-2019-315021. Epub 2019 Dec 11.

    PubMed 31826853

  • Yuzawa M, Fujita K, Wittrup-Jensen KU, Norenberg C, Zeitz O, Adachi K, Wang EC, Heier J, Kaiser P, Chong V, Korobelnik JF. Improvement in vision-related function with intravitreal aflibercept: data from phase 3 studies in wet age-related macular degeneration. Ophthalmology. 2015 Mar;122(3):571-8. doi: 10.1016/j.ophtha.2014.09.024. Epub 2014 Nov 6.

    PubMed 25439429

  • Ogura Y, Terasaki H, Gomi F, Yuzawa M, Iida T, Honda M, Nishijo K, Sowade O, Komori T, Schmidt-Erfurth U, Simader C, Chong V; VIEW 2 Investigators. Efficacy and safety of intravitreal aflibercept injection in wet age-related macular degeneration: outcomes in the Japanese subgroup of the VIEW 2 study. Br J Ophthalmol. 2015 Jan;99(1):92-7. doi: 10.1136/bjophthalmol-2014-305076. Epub 2014 Aug 8.

    PubMed 25107900

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ranibizumab and Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321) in people with Macular Degeneration, run by Bayer at 189 sites in 26 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 6 inclusion and 15 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 12 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 189 sites in Germany, Spain, India, Italy, Japan and 21 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. 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 23 Jan 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 Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF) (time frame: At week 52). 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 NCT00637377, which also lists 6 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 12 Dec 2014.

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