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CompletedNCT01217944Updated Feb 10, 2014Results posted

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

A Phase 3 interventional study of Ranibizumab and Verteporfin PDT in Pathological Myopia, sponsored by Novartis Pharmaceuticals. Completed at 74 sites in 20 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-02-10.

Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
277
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Pathological Myopia

Keywords

  • Pathologic myopia
  • PM
  • choroidal neovascularization
  • CNV
  • ranibizumab
  • verteporfin PDT
03

In context

Vision Disorders

308 studies on the registry are indexed under Vision Disorders; 81 are open to participants now.

This study's enrollment of 277 is above the median of 66 across 211 interventional studies indexed under Vision Disorders.

Browse Vision Disorders studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
277 participants (actual)

Study arms

  • Experimental
    Ranibizumab driven by disease activity

    Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria

    Drug: Ranibizumab · Drug: Sham Ranibizumab · Drug: Sham verteporfin PDT

  • Experimental
    Ranibizumab driven by stabilization criteria

    Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity

    Drug: Ranibizumab · Drug: Sham Ranibizumab · Drug: Sham verteporfin PDT

  • Active comparator
    Verteporfin PDT

    Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.

    Drug: Ranibizumab · Drug: Verteporfin PDT · Drug: Sham Ranibizumab · Drug: Sham verteporfin PDT

Interventions

  • DrugRanibizumab

    0.5 mg ranibizumab intravitreal injection

  • DrugVerteporfin PDT

    Verteporfin (6 mg/m2) intravenous infusion

    Also known as: vPDT

  • DrugSham Ranibizumab

    Empty vial to mimic the intravitreal injection

  • DrugSham verteporfin PDT

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

06

What researchers measure

Primary outcomes

  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.

    Time frame: Baseline, Month 1 through Month 3

Secondary outcomes

  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.

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

    Time frame: 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

    Time frame: 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.

    Time frame: Month 3 up to month 12

07

Results

Posted Oct 18, 2013

Participant flow

Out of the 334 patients screened, 277 patients were randomized into the study on a 2:2:1 basis: 106 patients to Group I (treatment with ranibizumab according to visual acuity stabilization), 116 patients to Group II (ranibizumab treatment according to disease activity), and 55 patients to Group III (treatment with vPDT)

Participant flow — Overall Study
Milestone0.5 mg Ranibizumab Driven by Stabilization Criteria0.5mg Ranibizumab Driven by Disease ActivityVerteporfin PDT
Started10611655
Completed 3 months10511655
Completed 6 months10311655
Completed10011255
Not completed640
Withdrew: Protocol violation110
Withdrew: Lost to follow-up310
Withdrew: Withdrawal by subject120
Withdrew: Lack of efficacy100

Outcome measures

PrimaryAverage 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.

Time frame:
Baseline, Month 1 through Month 3
Reported as:
Mean · Letters
Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye
Letters0.5 mg Ranibizumab Driven by Stabilization Criteria0.5mg Ranibizumab Driven by Disease ActivityVerteporfin PDT
Baseline55.4 ± 13.4355.8 ± 12.5954.7 ± 13.84
Average Month 1 to month 366.0 ± 12.9866.4 ± 12.2856.9 ± 14.49
SecondaryAverage 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.

Time frame:
Baseline and Month 6
Reported as:
Mean · Letters
Average Change From Baseline to Month 6 in Visual Acuity of the Study Eye
Letters0.5 mg Ranibizumab Driven by Stabilization Criteria0.5mg Ranibizumab Driven by Disease ActivityVerteporfin PDT
Baseline55.4 ± 13.4355.8 ± 12.5954.7 ± 13.84
Average month 1 to month 669.2 ± 12.4468.4 ± 13.5662.7 ± 14.65
SecondaryAverage 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

Time frame:
Baseline and Month 1 through Month 12
Reported as:
Mean · Letters
Average Change From Baseline to Month 1 Through Month 12 in Visual Acuity of the Study Eye
Letters0.5 mg Ranibizumab Driven by Stabilization Criteria0.5mg Ranibizumab Driven by Disease ActivityVerteporfin PDT
Baseline55.4 ± 13.4355.8 ± 12.5954.7 ± 13.84
Average Month 1 to Month 1268.3 ± 12.6168.3 ± 12.4561.1 ± 14.86
SecondaryPercentage 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.

Time frame:
Month 3
Reported as:
Number · Percentage of Patients
Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 3
Percentage of Patients0.5 mg Ranibizumab Driven by Stabilization Criteria0.5mg Ranibizumab Driven by Disease ActivityVerteporfin PDT
Month 3 >=15 letters38.143.114.5
Month 3 >= 10 letters61.965.527.3
SecondaryPercentage 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.

Time frame:
Months 6 and 12
Reported as:
Number · Percentage of Patients
Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 6 and Month 12
Percentage of Patients0.5 mg Ranibizumab Driven by Stabilization Criteria0.5mg Ranibizumab Driven by Disease ActivityVerteporfin PDT
Month 6 >=15 letters46.744.8—
Month 6 >= 10 letters71.464.7—
Month 12 >=15 letters53.351.7—
Month 12 >= 10 letters69.569.0—
SecondaryPercentage 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.

Time frame:
Month 3
Reported as:
Number · Percentage of Patients
Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 3
Percentage of Patients0.5 mg Ranibizumab Driven by Stabilization Criteria0.5mg Ranibizumab Driven by Disease ActivityVerteporfin PDT
Month 3 >=10 letters1.90.916.4
Month 3 >= 15 letters1.907.4
SecondaryPercentage 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.

Time frame:
Months 6 and 12
Reported as:
Number · Percentage of Patients
Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 6 and 12
Percentage of Patients0.5 mg Ranibizumab Driven by Stabilization Criteria0.5mg Ranibizumab Driven by Disease ActivityVerteporfin PDT
Month 6 >=10 letters1.92.6—
Month 6 >= 15 letters00.9—
Month 12 >=10 letters4.81.7—
Month 12 >= 15 letters1.90.9—
SecondaryChange 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.

Time frame:
Baseline, Month 3, Month 6 and Month 12
Reported as:
Mean · Microns
Change From Baseline in Central Retinal Thickness of the Study Eye Over Time
Microns0.5 mg Ranibizumab Driven by Stabilization Criteria0.5mg Ranibizumab Driven by Disease ActivityVerteporfin PDT
Baseline (n=102,110, 54)349.2 ± 95.05373.1 ± 127.44352.5 ± 101.52
Month 3 (n= 102,110,54)288.3 ± 70.14295.6 ± 71.93340.5 ± 106.03
Month 6 (n= 102,110,55)283.1 ± 67.43298.3 ± 81.16303.5 ± 76.81
Month 12 (n= 102,110,55)282.6 ± 68.62301.8 ± 88.16294.3 ± 83.25
SecondaryPercentage 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.

Time frame:
Baseline and Month 12
Reported as:
Number · Percentage of Patients
Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye
Percentage of Patients0.5 mg Ranibizumab Driven by Stabilization Criteria0.5mg Ranibizumab Driven by Disease ActivityVerteporfin PDT
Baseline-Definite96.293.1100.0
Baseline- Questionable1.00.00.0
Baseline-Absent1.00.90.0
Baseline- Other1.96.10.0
Month 12-Definite21.019.029.1
Month 12- Questionable0.00.01.8
Month 12-Absent68.669.865.5
Month 12- Other0.511.23.6
SecondaryNumber of Ranibizumab Injections Received Prior to Month 3

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

Time frame:
Day 1 and prior to month 3
Reported as:
Mean · injections
Number of Ranibizumab Injections Received Prior to Month 3
injections0.5 mg Ranibizumab Driven by Stabilization Criteria0.5mg Ranibizumab Driven by Disease ActivityVerteporfin PDT
Number of Ranibizumab Injections Received Prior to Month 32.5 ± 0.571.8 ± 0.820.0 ± 0.00
SecondaryNumber 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

Time frame:
Day 1 prior to month 6 and prior to month 12
Reported as:
Mean · injections
Number of Ranibizumab Injections Received by Patients Randomized to the Ranibizumab Groups, by Period
injections0.5 mg Ranibizumab Driven by Stabilization Criteria0.5mg Ranibizumab Driven by Disease Activity
Day 1 prior to Month 63.5 ± 1.462.5 ± 1.56
Day 1 prior to month 124.6 ± 2.593.5 ± 2.92
SecondaryNumber 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.

Time frame:
Month 3 up to month 12
Reported as:
Mean · injections
Number of Ranibizumab Injections Received by Patients Randomized to vPDT With Ranibizumab From Month 3 by Period
injectionsVerteporfin PDT
Day 1 up to month 6 (n=34)1.9 ± 0.86
Day 1 up to month 12 (n=38)3.2 ± 2.54

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
0.5 mg Ranibizumab Driven by Stabilization Criteria—7/106 (6.6%)46/106 (43.4%)
0.5mg Ranibizumab Driven by Disease Activity—6/118 (5.1%)47/118 (39.8%)
Visudyne PDT: Grp III With 0.5mg Ranibizumab From Month 3—0/38 (0%)17/38 (44.7%)
Visudyne PDT: Grp III Without 0.5mg Ranibizumab From Month 3—0/15 (0%)8/15 (53.3%)
Most frequent serious events
Showing 10 of 14
Most frequent serious events
Event0.5 mg Ranibizumab Driven by Stabilization Criteria0.5mg Ranibizumab Driven by Disease ActivityVisudyne PDT: Grp III With 0.5mg Ranibizumab From Month 3Visudyne PDT: Grp III Without 0.5mg Ranibizumab From Month 3
MyocarditisCardiac disorders1/1060/1180/380/15
Corneal erosion (Study eye)Eye disorders1/1060/1180/380/15
Gastritis erosiveGastrointestinal disorders1/1060/1180/380/15
Gastrointestinal haemorrhageGastrointestinal disorders1/1060/1180/380/15
Hepatic function abnormalHepatobiliary disorders1/1060/1180/380/15
Joint dislocationInjury, poisoning and procedural complications1/1060/1180/380/15
Breast cancer in situNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/1060/1180/380/15
DepressionPsychiatric disorders1/1060/1180/380/15
Atrial tachycardiaCardiac disorders0/1061/1180/380/15
Retinoschisis (Study eye)Eye disorders0/1061/1180/380/15
Most frequent other events
Showing 10 of 27
Most frequent other events
Event0.5 mg Ranibizumab Driven by Stabilization Criteria0.5mg Ranibizumab Driven by Disease ActivityVisudyne PDT: Grp III With 0.5mg Ranibizumab From Month 3Visudyne PDT: Grp III Without 0.5mg Ranibizumab From Month 3
NasopharyngitisInfections and infestations12/10612/1181/382/15
Conjunctival haemorrhage (Study eye)Eye disorders12/10612/1182/380/15
Intraocular pressure increased (Study eye)Investigations3/1067/1184/380/15
HeadacheNervous system disorders8/10611/1181/380/15
HypertensionVascular disorders3/1065/1183/380/15
Punctate keratitis (Study eye)Eye disorders8/1063/1182/380/15
TinnitusEar and labyrinth disorders0/1062/1180/381/15
Blindness (Study eye)Eye disorders0/1060/1181/381/15
Cataract (Study eye)Eye disorders1/1062/1180/381/15
Conjunctival hyperaemia (Study eye)Eye disorders1/1060/1180/381/15

Baseline characteristics

Age, Customized
Age, Customized(Participants)0.5 mg Ranibizumab Driven by Stabilization Criteria0.5mg Ranibizumab Driven by Disease ActivityVerteporfin PDTTotal
<45 years24 ± 22.624 ± 20.77 ± 12.755
45 -< 55 years27211664
55-<65 years30341478
>=6525371880
Sex: Female, Male
Sex: Female, Male(Participants)0.5 mg Ranibizumab Driven by Stabilization Criteria0.5mg Ranibizumab Driven by Disease ActivityVerteporfin PDTTotal
Female828740209
Male24291568
08

Study locations

74 sites
  • Novartis Investigative Site
    Linz, Upper Austria 4021, Austria
  • Novartis Investigative Site
    Wien, 1090, Austria
  • Novartis Investigative Site
    Vancouver, British Columbia V5Z 3N9, Canada
  • Novartis Investigative Site
    Montreal, Quebec H1T 2M4, Canada
  • Novartis Investigative Site
    Bordeaux Cedex, F-33076, France
  • Novartis Investigative Site
    Dijon, 21033, France
  • Novartis Investigative Site
    Paris, 75015, France
  • Novartis Investigative Site
    Reims, 51092, France
  • Novartis Investigative Site
    Toulouse, 31059, France
  • Novartis Investigative Site
    Berlin, 13353, Germany
  • Novartis Investigative Site
    Bonn, 53127, Germany
  • Novartis Investigative Site
    Freiburg, 79106, Germany
  • Novartis Investigative Site
    Hamburg, 20246, Germany
  • Novartis Investigative Site
    Koeln, 50924, Germany
  • Novartis Investigative Site
    Muenster, 48145, Germany
  • Novartis Investigative Site
    Muenster, 48149, Germany
  • Novartis Investigative Site
    München, 81675, Germany
  • Novartis Investigative Site
    Nuernberg, 90491, Germany
  • Novartis Investigative Site
    Regensburg, 93053, Germany
  • Novartis Investigative Site
    Hongkong, Hong Kong
  • Novartis Investigative Site
    Budapest, 1083, Hungary
  • Novartis Investigative Site
    Debrecen, 4004, Hungary
  • Novartis Investigative Site
    Mumbai, Maharashtra 400031, India
  • Novartis Investigative Site
    Chennai, Tamil Nadu 600006, India
  • Novartis Investigative Site
    Madurai, Tamil Nadu 625020, India
  • Novartis Investigative Site
    Bangalore, 560010, India
  • Novartis Investigative Site
    New Delhi, 110 029, India
  • Novartis Investigative Site
    Bari, BA 70124, Italy
  • Novartis Investigative Site
    Firenze, FI 50134, Italy
  • Novartis Investigative Site
    Milano, MI 20132, Italy
  • Novartis Investigative Site
    Milano, MI 20157, Italy
  • Novartis Investigative Site
    Udine, UD 33100, Italy
  • Novartis Investigative Site
    Nagoya-city, Aichi 466-8560, Japan
  • Novartis Investigative Site
    Nagoya-city, Aichi 467-8602, Japan
  • Novartis Investigative Site
    Fukuoka-city, Fukuoka 812-8582, Japan
  • Novartis Investigative Site
    Fukushima-city, Fukushima 960-1295, Japan
  • Novartis Investigative Site
    Sapporo-city, Hokkaido 060-8648, Japan
  • Novartis Investigative Site
    Kita-gun, Kagawa 761-0793, Japan
  • Novartis Investigative Site
    Matsumoto, Nagano 390-8621, Japan
  • Novartis Investigative Site
    Hirakata-city, Osaka 573-1191, Japan
  • Novartis Investigative Site
    Suita-city, Osaka 565-0871, Japan
  • Novartis Investigative Site
    Bunkyo-ku, Tokyo 113-8519, Japan
  • Novartis Investigative Site
    Bunkyo-ku, Tokyo 113-8655, Japan
  • Novartis Investigative Site
    Chiyoda-ku, Tokyo 101-8309, Japan
  • Novartis Investigative Site
    Mitaka-city, Tokyo 181-8611, Japan
  • Novartis Investigative Site
    Kyoto, 606-8507, Japan
  • Novartis Investigative Site
    Seoul, Korea 110 744, Korea, Republic of
  • Novartis Investigative Site
    Seoul, Korea 120-752, Korea, Republic of
  • Novartis Investigative Site
    Seoul, Korea 135-710, Korea, Republic of
  • Novartis Investigative Site
    Seoul, 738-736, Korea, Republic of
  • Novartis Investigative Site
    Riga, 1002, Latvia
  • Novartis Investigative Site
    Kaunas, LT-50009, Lithuania
  • Novartis Investigative Site
    Vilnius, LT-08661, Lithuania
  • Novartis Investigative Site
    Bielsko-Biala, 43-300, Poland
  • Novartis Investigative Site
    Coimbra, 3000-075, Portugal
  • Novartis Investigative Site
    Porto, 4200-319, Portugal
  • Novartis Investigative Site
    Singapore, 168751, Singapore
  • Novartis Investigative Site
    Singapore, 308433, Singapore
  • Novartis Investigative Site
    Singapore, 768825, Singapore
  • Novartis Investigative Site
    Banska Bystrica, Slovak Republic 975 17, Slovakia
  • Novartis Investigative Site
    Bratislava, 82606, Slovakia
  • Novartis Investigative Site
    Valladolid, Castilla y Leon 47011, Spain
  • Novartis Investigative Site
    Hospitalet de Llobregat, Cataluña 08907, Spain
  • Novartis Investigative Site
    Alicante, Comunidad Valenciana 03016, Spain
  • Novartis Investigative Site
    Bilbao, Pais Vasco 48006, Spain
  • Novartis Investigative Site
    Bern, 3010, Switzerland
  • Novartis Investigative Site
    Genève, 1204, Switzerland
  • Novartis Investigative Site
    Lausanne, 1007, Switzerland
  • Novartis Investigative Site
    Ankara, 06100, Turkey
  • Novartis Investigative Site
    Ankara, 06490, Turkey
  • Novartis Investigative Site
    Etlik / Ankara, 06018, Turkey
  • Novartis Investigative Site
    Belfast, BT12 6BA, United Kingdom
  • Novartis Investigative Site
    Bristol, BS1 2LX, United Kingdom
  • Novartis Investigative Site
    Wolverhampton, WV10 0QP, United Kingdom
09

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01217944
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Oct 8, 2010
Start date
Oct 2010
Primary completion
Aug 2012
Completion
Aug 2012
Results posted
Oct 18, 2013
Last update
Feb 10, 2014

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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