AzTrials
AzTrials

Pathological MyopiaPhase 3NCT01217944

Efficacy and Safety of Ranibizumab in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia

A Phase 3 study testing Ranibizumab and Verteporfin PDT in people with Pathological Myopia, run by Novartis Pharmaceuticals at 74 sites in 20 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 designed to evaluate the efficacy and safety of two different dosing regimens of 0.5 mg ranibizumab given as intravitreal injection in comparison to verteporfin PDT in patients with visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia (PM). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pathological Myopia
What is being tested?
Ranibizumab and Verteporfin PDT
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
277 participants
Where
74 sitesin 20 countries
Study dates
Oct 2010to Aug 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

  • Visual impairment due to choroidal neovascularization (CNV) secondary to PM
  • Best corrected visual acuity (BCVA) in the study eye > 24 and < 78 Early Treatment Diabetic Retinopathy Study (ETDRS) letters
  • High myopia (> -6D), anterior-posterior elongation > 26 mm; posterior changes compatible with the pathologic myopia
  • Either lesion types in the study eye: subfoveal, juxtafoveal, extrafoveal

Who cannot join

  • Patients with uncontrolled systemic or ocular diseases
  • Blood pressure > 150/90 mmHg
  • History of pan-retinal, focal/grid laser photocoagulation or intraocular treatment with any anti-VEGF or vPDT in the study eye
  • Intravitreal treatment with corticosteroids or intraocular surgery within last 3 months in the study eye
  • Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

74 sites in 20 countries.

74 sites in 20 countries

Japan14 sites

  • Novartis Investigative Site

    Bunkyo-ku, Tokyo, 113-8519

  • Novartis Investigative Site

    Bunkyo-ku, Tokyo, 113-8655

  • Novartis Investigative Site

    Chiyoda-ku, Tokyo, 101-8309

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 812-8582

  • Novartis Investigative Site

    Fukushima, Fukushima, 960-1295

  • Novartis Investigative Site

    Hirakata, Osaka, 573-1191

  • Novartis Investigative Site

    Kita-gun, Kagawa-ken, 761-0793

  • Novartis Investigative Site

    Kyoto, Kyoto, 606-8507

  • Novartis Investigative Site

    Matsumoto, Nagano, 390-8621

  • Novartis Investigative Site

    Mitaka, Tokyo, 181-8611

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 466-8560

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 467-8602

  • Novartis Investigative Site

    Sapporo, Hokkaido, 060-8648

  • Novartis Investigative Site

    Suita, Osaka, 565-0871

Other trials in Japan

Germany10 sites

  • Novartis Investigative Site

    Berlin, 13353

  • Novartis Investigative Site

    Bonn, 53127

  • Novartis Investigative Site

    Cologne, 50924

  • Novartis Investigative Site

    Freiburg im Breisgau, 79106

  • Novartis Investigative Site

    Hamburg, 20246

  • Novartis Investigative Site

    München, 81675

  • Novartis Investigative Site

    Münster, 48145

  • Novartis Investigative Site

    Münster, 48149

  • Novartis Investigative Site

    Nuremberg, 90491

  • Novartis Investigative Site

    Regensburg, 93053

Other trials in Germany

France5 sites

  • Novartis Investigative Site

    Bordeaux, France, F-33076

  • Novartis Investigative Site

    Dijon, 21033

  • Novartis Investigative Site

    Paris, 75015

  • Novartis Investigative Site

    Reims, 51092

  • Novartis Investigative Site

    Toulouse, 31059

Other trials in France

India5 sites

  • Novartis Investigative Site

    Bangalore, 560010

  • Novartis Investigative Site

    Chennai, Tamil Nadu, 600006

  • Novartis Investigative Site

    Madurai, Tamil Nadu, 625020

  • Novartis Investigative Site

    Mumbai, Maharashtra, 400031

  • Novartis Investigative Site

    New Delhi, New Delhi, 110 029

Other trials in India

Italy5 sites

  • Novartis Investigative Site

    Bari, BA, 70124

  • Novartis Investigative Site

    Florence, FI, 50134

  • Novartis Investigative Site

    Milan, MI, 20132

  • Novartis Investigative Site

    Milan, MI, 20157

  • Novartis Investigative Site

    Udine, UD, 33100

Other trials in Italy

South Korea4 sites

  • Novartis Investigative Site

    Seoul, Korea, 110 744

  • Novartis Investigative Site

    Seoul, Korea, 120-752

  • Novartis Investigative Site

    Seoul, Korea, 135-710

  • Novartis Investigative Site

    Seoul, 738-736

Other trials in South Korea

Spain4 sites

  • Novartis Investigative Site

    Alicante, Valencia, 03016

  • Novartis Investigative Site

    Bilbao, Basque Country, 48006

  • Novartis Investigative Site

    L'Hospitalet de Llobregat, Catalonia, 08907

  • Novartis Investigative Site

    Valladolid, Castille and León, 47011

Other trials in Spain

Singapore3 sites

  • Novartis Investigative Site

    Singapore, Singapore, 308433

  • Novartis Investigative Site

    Singapore, Singapore, 768825

  • Novartis Investigative Site

    Singapore, 168751

Other trials in Singapore

Switzerland3 sites

  • Novartis Investigative Site

    Bern, 3010

  • Novartis Investigative Site

    Geneva, 1204

  • Novartis Investigative Site

    Lausanne, 1007

Other trials in Switzerland

Turkey (Türkiye)3 sites

  • Novartis Investigative Site

    Ankara, Turkey, 06100

  • Novartis Investigative Site

    Ankara, Turkey, 06490

  • Novartis Investigative Site

    Etlik / Ankara, 06018

Other trials in Turkey (Türkiye)

United Kingdom3 sites

  • Novartis Investigative Site

    Belfast, BT12 6BA

  • Novartis Investigative Site

    Bristol, BS1 2LX

  • Novartis Investigative Site

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Austria2 sites

  • Novartis Investigative Site

    Linz, Upper Austria, 4021

  • Novartis Investigative Site

    Vienna, Austria, 1090

Other trials in Austria

Canada2 sites

  • Novartis Investigative Site

    Montreal, Quebec, H1T 2M4

  • Novartis Investigative Site

    Vancouver, British Columbia, V5Z 3N9

Other trials in Canada

Hungary2 sites

  • Novartis Investigative Site

    Budapest, 1083

  • Novartis Investigative Site

    Debrecen, 4004

Other trials in Hungary

Lithuania2 sites

  • Novartis Investigative Site

    Kaunas, LT-50009

  • Novartis Investigative Site

    Vilnius, LT-08661

Other trials in Lithuania

Portugal2 sites

  • Novartis Investigative Site

    Coimbra, 3000-075

  • Novartis Investigative Site

    Porto, 4200-319

Other trials in Portugal

Slovakia2 sites

  • Novartis Investigative Site

    Banská Bystrica, Slovak Republic, 975 17

  • Novartis Investigative Site

    Bratislava, Slovakia, 82606

Other trials in Slovakia

Hong Kong1 site

  • Novartis Investigative Site

    Hong Kong, Hong Kong

Other trials in Hong Kong

Latvia1 site

  • Novartis Investigative Site

    Riga, 1002

Other trials in Latvia

Poland1 site

  • Novartis Investigative Site

    Bielsko-Biala, 43-300

Other trials in Poland

About this study

Official title: A 12 Month, Phase III, Randomized, Double-masked, Multicenter, Active-controlled Study to Evaluate the Efficacy and Safety of Two Different Dosing Regimens of 0.5 mg Ranibizumab vs. Verteporfin PDT in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia

This study is designed to evaluate the efficacy and safety of two different dosing regimens of 0.5 mg ranibizumab given as intravitreal injection in comparison to verteporfin PDT in patients with visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia (PM).

Being tested
Ranibizumab, Verteporfin PDT, Sham Ranibizumab, Sham verteporfin PDT
Keywords
Pathologic myopia, PM, choroidal neovascularization, CNV, ranibizumab, verteporfin PDT
Medical subject headings
Myopia, Degenerative, Choroidal Neovascularization

What participants receive

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

  • RanibizumabDrug

    0.5 mg ranibizumab intravitreal injection

  • Verteporfin PDTDrug

    Also called vPDT

    Verteporfin (6 mg/m2) intravenous infusion

  • Sham RanibizumabDrug

    Empty vial to mimic the intravitreal injection

  • Sham verteporfin PDTDrug

    Sham vPDT intravenous infusion of dextrose 5% solution followed by light application (PDT).

Study groups in NCT01217944
Study groupRoleWhat they receive
Ranibizumab driven by disease activityExperimentalParticipants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
Receives: Drug: Ranibizumab; Drug: Sham Ranibizumab; Drug: Sham verteporfin PDT
Ranibizumab driven by stabilization criteriaExperimentalParticipants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity
Receives: Drug: Ranibizumab; Drug: Sham Ranibizumab; Drug: Sham verteporfin PDT
Verteporfin PDTActive comparatorParticipants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
Receives: Drug: Ranibizumab; Drug: Verteporfin PDT; Drug: Sham Ranibizumab; Drug: Sham verteporfin PDT

What is being measured

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

  1. Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye

    The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and compared to the average from month 1 to month 3.

    Measured: Baseline, Month 1 through Month 3

Secondary outcomes (11)

  1. Average Change From Baseline to Month 6 in Visual Acuity of the Study Eye

    The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and month 6. The overall BCVA score was calculated using the BCVA worksheet.

    Measured: Baseline and Month 6

  2. Average Change From Baseline to Month 1 Through Month 12 in Visual Acuity of the Study Eye

    The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and Month 1 through 12

    Measured: Baseline and Month 1 through Month 12

  3. Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 3

    BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained more than 10 or more than 15 of visual acuity at month 3.

    Measured: Month 3

  4. Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 6 and Month 12

    BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained more than 10 or more than 15 letters of visual acuity at month 6 and month 12.

    Measured: Months 6 and 12

  5. Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 3

    BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. A decreased score indicates worsening in acuity. This outcome assessed the percentage of participants who lost more than 10 or more than 15 of visual acuity at month 3.

    Measured: Month 3

  6. Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 6 and 12

    BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. A decreased score indicates worsening in acuity. This outcome assessed the percentage of participants who lost more than 10 or more than 15 of visual acuity at month 6 and 12.

    Measured: Months 6 and 12

  7. Change From Baseline in Central Retinal Thickness of the Study Eye Over Time

    Retinal thickness was measured by Central Reading Center using patient's Optical Coherence Tomography (OCT) images provided by investigators.

    Measured: Baseline, Month 3, Month 6 and Month 12

  8. Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye

    CNV leakage assessment plus other choroid and retinal disorders were assessed by Central Reading Center using patient's fluorescein angiography and color fundus photography images provided by investigators.

    Measured: Baseline and Month 12

  9. Number of Ranibizumab Injections Received Prior to Month 3

    In order to describe exposure to the study drug the number of ejections was evaluated

    Measured: Day 1 and prior to month 3

  10. Number of Ranibizumab Injections Received by Patients Randomized to the Ranibizumab Groups, by Period

    Number of ranibizumab injections received by patients randomized to the ranibizumab groups, by period

    Measured: Day 1 prior to month 6 and prior to month 12

  11. Number of Ranibizumab Injections Received by Patients Randomized to vPDT With Ranibizumab From Month 3 by Period

    Number of ranibizumab injections received by patients randomized to the vPDT with ranibizumab groups, by period.

    Measured: Month 3 up to month 12

Timeline

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

  1. First posted8 Oct 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionAug 2012
  4. Study completionAug 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
277 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01217944
Sponsor's protocol ID
CRFB002F2301
Other IDs
2010-021662-30
Status last verified
Jan 2014
First submitted
6 Oct 2010
Last updated
10 Feb 2014

Publications

  • Ceklic L, Wolf-Schnurrbusch U, Gekkieva M, Wolf S. Visual acuity outcome in RADIANCE study patients with dome-shaped macular features. Ophthalmology. 2014 Nov;121(11):2288-9. doi: 10.1016/j.ophtha.2014.06.012. Epub 2014 Aug 8. No abstract available.

    PubMed 25109929

  • Wolf S, Balciuniene VJ, Laganovska G, Menchini U, Ohno-Matsui K, Sharma T, Wong TY, Silva R, Pilz S, Gekkieva M; RADIANCE Study Group. RADIANCE: a randomized controlled study of ranibizumab in patients with choroidal neovascularization secondary to pathologic myopia. Ophthalmology. 2014 Mar;121(3):682-92.e2. doi: 10.1016/j.ophtha.2013.10.023. Epub 2013 Dec 8.

    PubMed 24326106

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ranibizumab and Verteporfin PDT in people with Pathological Myopia, run by Novartis Pharmaceuticals at 74 sites in 20 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 4 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 10 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in Japan, Germany, France, India, Italy and 15 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 18 Oct 2013). 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?

Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye (time frame: Baseline, Month 1 through Month 3). 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 NCT01217944, 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 10 Feb 2014.

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