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Trial record 2 of 7 for:    EVEREST II

Visual Outcome in Patients With Symptomatic Macular PCV Treated With Either Ranibizumab as Monotherapy or Combined With Verteporfin Photodynamic Therapy. (EVEREST II)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01846273
First Posted: May 3, 2013
Last Update Posted: November 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
April 29, 2013
May 3, 2013
November 1, 2017
August 7, 2013
March 11, 2016   (Final data collection date for primary outcome measure)
  • Change from Baseline in in Visual Acuity (Letters) of the Study Eye to Month 12 [ Time Frame: Baseline to Month 12 ]
  • Complete polyp regression assessed by ICGA at Month 12 [ Time Frame: Month 12 ]
Same as current
Complete list of historical versions of study NCT01846273 on ClinicalTrials.gov Archive Site
  • Change from Baseline in Visual Acuity (Letters) of the Study Eye over time [ Time Frame: Baseline to Month 24 ]
  • Gain of equal or more than 5, 10, or 15 letters in Visual Acuity of the Study Eye up to Month 24 [ Time Frame: Baseline to Month 24 ]
  • Loss of less than 5, 10, 15, and 30 letters in Visual Acuity in the Study Eye from baseline to Month 24 [ Time Frame: Baseline to Month 24 ]
  • Maintenance of Visual Acuity of the Study Eye at Month 12 and 24 compared to the time point of first treatment interruption [ Time Frame: Month 3 to Month 12 and 24 ]
  • Change in Visual Acuity (Letters) of the Study Eye at Month 12 and 24 compared to the timepoint of first treatment interruption [ Time Frame: Month 3 to Month 12 and 24 ]
  • Occurrence of complete polyp regression in the Study Eye as assessed by ICGA at Months 6 and 24 [ Time Frame: Month 6 and 24 ]
  • Presence of leakage in the Study Eye based on fluorescein angiography at Months 6, 12 and 24 [ Time Frame: Months 6,12, and ]
  • Change from Baseline in Central Subfield Retinal Thickness (CSRT) of the Study Eye over time [ Time Frame: Baseline to Month 24 ]
  • Total number of treatments with ranibizumab in the Study Eye and total number of treatments with verteporfin PDT from baseline to Month 12 and 24 [ Time Frame: Baseline to Month 12 and 24 ]
  • Total number of treatments in the Study Eye with ranibizumab from Month 3 to Month 12 and 24 [ Time Frame: Month 3 to Month 12 and 24 ]
  • National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) scores at baseline, Months 3, 12, and 24, and change from baseline over time [ Time Frame: Baseline to Month 24 ]
  • Frequency and severity of ocular and non-ocular adverse events over time [ Time Frame: Screening to Month 24 ]
Same as current
Not Provided
Not Provided
 
Visual Outcome in Patients With Symptomatic Macular PCV Treated With Either Ranibizumab as Monotherapy or Combined With Verteporfin Photodynamic Therapy.
A 24-month, Phase IV, Randomized, Double Masked, Multi-center Study of Ranibizumab Monotherapy or Ranibizumab in Combination With Verteporfin Photodynamic Therapy on Visual Outcome in Patients With Symptomatic Macular PCV
This study will compare the effect of ranibizumab administered as monotherapy versus ranibizumab administered in combination with verteporfin PDT on visual acuity in patients with symptomatic macular PCV. The results of this study will provide long-term safety and efficacy data used to generate further guidance on the management of patients with PCV.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Age-related Macular Degeneration
  • Polypoidal Choroidal Vasculopathy PCV
  • Drug: Ranibizumab
    Intravitreal injections or 0.5 mg ranibizumab
  • Drug: Verteporfin PDT
    Infusion of 30 ml verteporfin in 5% dextrose solution followed by 83 sec of laser light (50J/cm2; 600mW/cm2; 689 nm)
  • Drug: Sham PDT
    Infusion of 30 ml 5% dextrose solution followed by 83 sec of laser light (50J/cm2; 600mW/cm2; 689 nm)
  • Experimental: Ranibizumab plus verteporfin PDT
    After treatment initiation with combination therapy of ranibizumab and verteporfin PDT, re-treatment need with either ranibizumab alone or combined with verteporfin PDT will be determined at monthly visits based on defined retreatment criteria
    Interventions:
    • Drug: Ranibizumab
    • Drug: Verteporfin PDT
  • Active Comparator: Ranibizumab monotherapy
    After treatment initiation with combination therapy of ranibizumab and sham PDT, re-treatment need with either ranibizumab alone or combined with sham PDT will be determined at monthly visits based on defined retreatment criteria.
    Interventions:
    • Drug: Ranibizumab
    • Drug: Sham PDT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
321
March 2, 2017
March 11, 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Confirmed diagnosis of symptomatic macular PCV in the study eye
  • A qualifying vision score at study entry
  • A qualifying lesion size in the study eye at study entry

Exclusion Criteria:

  • Active inflammation or infection in the study eye
  • Uncontrolled intraocular pressure in the stuy eye
  • Ocular condition in the study eye which may impact vision and confound study outcomes
  • Prior treatment of the study eye with anti-VEGF therapy, verteporfin PDT, other laser and surgical interventions, intraocular corticosteroids
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Hong Kong,   Japan,   Korea, Republic of,   Malaysia,   Singapore,   Taiwan,   Thailand
 
 
NCT01846273
CRFB002A2412
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP