Efficacy and Safety of Ranibizumab 0.5 vs Veteporfin PDT in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia (Brilliance)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01922102
First received: August 12, 2013
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

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 secondary to pathologic myopia (PM)


Condition Intervention Phase
Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia
Drug: Ranibizumab 0.5mg
Drug: Rranibizumab 0.5 mg
Drug: Verteporfin PDT
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 12-month, Phase III, Randomized, Double-masked, Multicenter, Active-controlled Study to Evaluate the Efficacy and Safety of Two Individualized Regimens of 0.5mg Ranibizumab vs. Verteporfin PDT in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • change from baseline BCVA to the average level of BCVA (letters) over all monthly post-baseline assessments: BCVA change; by measuring BCVA score at 4 meters distance using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts [ Time Frame: Month 1 to Month 3 ] [ Designated as safety issue: No ]
    Superior efficacy of 0.5 mg ranibizumab administered based on visual acuity stability criteria and/or disease activity re-treatment criteria compared to vPDT


Secondary Outcome Measures:
  • average level of BCVA (letters); BCVA change; by measuring BCVA score at 4 meters distance using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts [ Time Frame: Month 1 to Month 6 ] [ Designated as safety issue: No ]
    demonstrate non-inferiority of 0.5 mg ranibizumab intravitreal injections driven by disease activity re-treatment criteria versus 0.5 mg ranibizumab intravitreal injections driven by visual acuity stability criteria as assessed by the change from baseline BCVA to the average level of BCVA over all monthly assessments from Month 1 to Month 6.

  • average level of BCVA (letters); BCVA change; by measuring BCVA score at 4 meters distance using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To compare the efficacy of the ranibizumab treatment groups as assessed by the change from baseline BCVA to the average level of BCVA over all monthly assessments from Month 1 to Month 12 and based on the time course of BCVA changes from baseline

  • Improvement in BCVA; BCVA score measured at 4 meters distance using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    To compare BCVA improvement ≥10 and ≥15 letters or BCVA reaching 84 letters, and BCVA loss ≥10 and ≥15 letters for each month between treatment groups

  • Change in retinal thickness measured on OCT image by Reading center [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    To evaluate the time course of CRT/CSFT changes from baseline in the treatment groups

  • CNV leakage presence measured on Fluorescein angiography image by Reading center [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    To compare presence of active leakage over time up to Month 12 in the treatment groups

  • Quality of Life [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    To assess the impact on patient functioning and quality of life supported by ranibizumab 0.5 versus vPDT as assessed by the NEI-VFQ-25

  • Number of injections and period (time) between injections [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    To assess treatment pattern with ranibizumab

  • Occurrence and incidence of the AEs [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    To assess the safety and tolerability of 0.5 mg ranibizumab and vPDT


Estimated Enrollment: 475
Study Start Date: September 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group I
0.5 mg ranibizumab driven by visual acuity stability criteria
Drug: Ranibizumab 0.5mg
0.5 mg ranibizumab (intravitreal injections)
Other Name: Lucentis
Experimental: Group II
0.5 mg ranibizumab driven by disease activity criteria
Drug: Rranibizumab 0.5 mg
0.5 mg ranibizumab (intravitreal injections)
Other Name: Lucentis
Active Comparator: Group III
verteporfin PDT
Drug: Verteporfin PDT
Verteporfin for intravenous injection delivered by intravenous infusion followed by the light application
Other Name: Visudyne

Detailed Description:

This is a phase III, multi-center, randomized, double-masked, active-controlled study comparing 0.5 mg ranibizumab vs. vPDT therapy. The study includes 15 scheduled visits over 12 months, and there will be two additional visits (2a, 3a) for subset of patients in whom PK analysis will be performed.

There will be 3 periods in this study: Screening period-from Day -14 to Baseline; Treatment period-from Baseline to Month 11; Follow-up period-from Month 11 to Month 12 Patients will enter the 11 months Treatment period at Visit 2 (Day 1) if eligibility criteria are met and will be randomized in three treatment groups Group I ranibizumab 0.5 mg driven by VA stability criteria or Group II ranibizumab 0.5 mg driven by disease activity criteria or Group III vPDT (randomization ratio of 2:2:1) and will receive first treatment of either a ranibizumab injection and sham vPDT or sham injection and active vPDT and will return to the clinical center within 7 days to undergo safety assessments as well as assessments of the effect of treatment by the evaluating investigator. The following visits will be performed at one month intervals starting at Visit 4 and continuing through Visit 14.At all monthly visits (at/from Month 2 for group I, at/from Month 1 for group II and at/from Month 3 for group III) the decision for treatment will be made by the evaluating investigator based on the VA stability criteria and on the disease activity criteria. At Month 3 (visit 6) and at all following monthly visits for all three groups one of the three options can recommended by evaluating investigator: a) ranibizumab 0.5 mg, b) ranibizumab 0.5 mg + vPDT; c) vPDT. The treating investigator will then perform treatment based on randomization and masking requirements.

At each monthly visit, patients will have a safety evaluation by the evaluating investigator prior to study treatment, consisting of visual acuity measurements, ophthalmic examinations and evaluation of adverse events and vital signs. Routine hematology, chemistry, and urinalysis profiles will be obtained at Visit 6, 9 and 12 (Month 3, 6 and 9). At Month 12 several procedures and assessments will be performed which are required at study completion visit.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Visual impairment due to CNV secondary to PM.
  • Best corrected visual acuity in the study eye > 24 and < 78 ETDRS letters.
  • High myopia (> -6D),
  • anterio-posterior elongation > 26 mm; posterior changes compatible with the pathologic myopia.
  • Either CNV locations in the study eye: subfoveal, juxtafoveal, extrafoveal.

Exclusion Criteria:

  • Some preexisting eye disorders or systemic diseases;-Blood pressure > 150/90 mmHg
  • Prior focal/grid laser to the macular area -History of treatment with any anti-VEGF or verteporfin PDT 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01922102

Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

  Show 47 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01922102     History of Changes
Other Study ID Numbers: CRFB002F2302
Study First Received: August 12, 2013
Last Updated: June 5, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Novartis:
Pathologic myopia (PM), choroidal neovascularization (CNV), ranibizumab, verteporfin PDT, Brilliance

Additional relevant MeSH terms:
Refractive Errors
Myopia
Neovascularization, Pathologic
Vision, Low
Vision Disorders
Choroidal Neovascularization
Eye Diseases
Metaplasia
Pathologic Processes
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Choroid Diseases
Uveal Diseases
Verteporfin
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014