Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Trial record 2 of 8 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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01846273
First received: April 29, 2013
Last updated: July 19, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention Phase
Age-related Macular Degeneration; Polypoidal Choroidal Vasculopathy (PCV)
Drug: Ranibizumab
Drug: Verteporfin PDT
Drug: Sham PDT
Phase 4

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 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from Baseline in in Visual Acuity (Letters) of the Study Eye to Month 12 [ Time Frame: Baseline to Month 12 ] [ Designated as safety issue: No ]
  • Complete polyp regression assessed by ICGA at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in Visual Acuity (Letters) of the Study Eye over time [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Occurrence of complete polyp regression in the Study Eye as assessed by ICGA at Months 6 and 24 [ Time Frame: Month 6 and 24 ] [ Designated as safety issue: No ]
  • Presence of leakage in the Study Eye based on fluorescein angiography at Months 6, 12 and 24 [ Time Frame: Months 6,12, and ] [ Designated as safety issue: No ]
  • Change from Baseline in Central Subfield Retinal Thickness (CSRT) of the Study Eye over time [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Frequency and severity of ocular and non-ocular adverse events over time [ Time Frame: Screening to Month 24 ] [ Designated as safety issue: Yes ]

Enrollment: 321
Study Start Date: August 2013
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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)
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.
Drug: Ranibizumab
Intravitreal injections or 0.5 mg ranibizumab
Drug: Sham PDT
Infusion of 30 ml 5% dextrose solution followed by 83 sec of laser light (50J/cm2; 600mW/cm2; 689 nm)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01846273

  Show 42 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01846273     History of Changes
Other Study ID Numbers: CRFB002A2412 
Study First Received: April 29, 2013
Last Updated: July 19, 2016
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency
Singapore: Health Sciences Authority
Thailand: Food and Drug Administration
South Korea: Korea Food and Drug Administration (KFDA)
Malaysia: Ministry of Health
Hong Kong: Department of Health
Taiwan: Department of Health

Additional relevant MeSH terms:
Macular Degeneration
Vascular Diseases
Retinal Degeneration
Retinal Diseases
Eye Diseases
Cardiovascular Diseases
Ranibizumab
Verteporfin
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Photosensitizing Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on December 09, 2016