An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases. (ECLIPSE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01908816
First received: July 20, 2013
Last updated: July 19, 2016
Last verified: July 2016
  Purpose
The pupose of this study is to evaluate the safety and the efficacy of ranibizumab in rare VEGF driven ocular diseases.

Condition Intervention Phase
Choroidal Neovascularization
Macular Edema
Glaucoma, Neovascular
Diabetic Retinopathy
Drug: ranibizumab
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Rate and severity of serious and non-serious, ocular and non-ocular adverse events [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Average change of BCVA for patients with CNV and ME [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    BCVA will be tested using the ETDRS, the Snellen or Monoyer scales. VA measurements will be preferentially taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score will be calculated using the BCVA worksheet which will be kept in the source data and the score will be recorded in the eCRF. ETDRS, Snellen and Monoyer VA measurements will be transformed in logMAR to be analyzed.

  • Average change of neovascularization extension for patients with neovascular glaucoma [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Change of the extent of iris neovascularization using "Teich and Walsh grading system" using iris photography

  • Proportion of patient with Vitreous Cavity Hemorrhage occurrence for patient with proliferative retinopathy [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Occurrence of postoperative vitreous cavity hemorrhage


Enrollment: 272
Study Start Date: September 2013
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ranibizumab Drug: ranibizumab
One injection of Ranibizumab 0.5 mg and retreatment according to disease activity and/or visual impairment on an as needed regimen (PRN)

  Eligibility

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

Inclusion Criteria:

  • Active choroidal neovascularization (CNV)
  • Active macular edema (ME)
  • Rubeosis iridis/neovascular glaucoma.
  • Proliferative diabetic retinopathy requiring vitrectomy.

Exclusion Criteria:

  • wet Age-related macular degeneration
  • pathologic myopia
  • pseudoxanthoma elasticum
  • diabetic macular edema
  • retinal vein occlusion
  • < 18 years of age
  • History of hypersensitivity to ranibizumab
  • Use of any systemic anti-angiogenic drugs 3 months before inclusion
  • Women of child-bearing potential and Pregnant or nursing (lactating) women.
  • Active or suspected ocular infection
  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: NCT01908816

Locations
France
Novartis Investigative Site
Amiens Cedex 1, France, 80054
Novartis Investigative Site
Angers, France, 49044
Novartis Investigative Site
Bobigny, France, 93009
Novartis Investigative Site
Bordeaux, France, 33100
Novartis Investigative Site
Bordeaux, France, 33000
Novartis Investigative Site
Caen, France, 14050
Novartis Investigative Site
Créteil, France, 94000
Novartis Investigative Site
Ecully, France
Novartis Investigative Site
Grenoble, France, 38000
Novartis Investigative Site
Grenoble, France, 38043
Novartis Investigative Site
Lille, France, 59000
Novartis Investigative Site
Lyon, France, 69275
Novartis Investigative Site
Lyon Cedex 04, France, 69317
Novartis Investigative Site
Mantes la jolie, France, 78201
Novartis Investigative Site
Marseille, France, F-13008
Novartis Investigative Site
Marseille Cedex 8, France, 13008
Novartis Investigative Site
Melun, France, 77000
Novartis Investigative Site
Montauban, France, 82000
Novartis Investigative Site
Montpellier, France, 34000
Novartis Investigative Site
Mulhouse cedex, France, 68070
Novartis Investigative Site
Nantes Cedex 1, France, 44093
Novartis Investigative Site
Nice, France, 06000
Novartis Investigative Site
Paris, France, 75015
Novartis Investigative Site
Paris, France, 75007
Novartis Investigative Site
Paris, France, 75013
Novartis Investigative Site
Paris, France, 75006
Novartis Investigative Site
Paris, France, 75014
Novartis Investigative Site
Paris cedex 10, France, 75010
Novartis Investigative Site
Paris Cedex 19, France, 75940
Novartis Investigative Site
Paris, Cedex 12, France, F-75571
Novartis Investigative Site
Poitiers, France, 86021
Novartis Investigative Site
Rouen, France, 76100
Novartis Investigative Site
Saint-Jean, France, 31240
Novartis Investigative Site
Saitnt Herblain, France, 44819
Novartis Investigative Site
St-Priest-en-Jarez, France, 42270
Novartis Investigative Site
Strasbourg Cedex, France, 67091
Novartis Investigative Site
Toulouse, France, 31077
Novartis Investigative Site
Tours, France, 37000
Novartis Investigative Site
Tours, France, 37044
Novartis Investigative Site
Vannes, France, 56000
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01908816     History of Changes
Other Study ID Numbers: CRFB002GFR02 
Study First Received: July 20, 2013
Last Updated: July 19, 2016
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Glaucoma
Macular Edema
Diabetic Retinopathy
Neovascularization, Pathologic
Choroidal Neovascularization
Glaucoma, Neovascular
Ocular Hypertension
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases
Ranibizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 21, 2016