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

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:
NCT01908816
First received: July 20, 2013
Last updated: June 5, 2014
Last verified: June 2014
  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


Estimated Enrollment: 500
Study Start Date: September 2013
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (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
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

Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

Locations
France
Novartis Investigative Site Not yet recruiting
Angers, France, 49044
Novartis Investigative Site Not yet recruiting
Bordeaux, France, 33000
Novartis Investigative Site Not yet recruiting
Bordeaux, France, 33100
Novartis Investigative Site Not yet recruiting
Grenoble, France, 38000
Novartis Investigative Site Not yet recruiting
Lagord, France, 17140
Novartis Investigative Site Not yet recruiting
Melun, France, 77000
Novartis Investigative Site Not yet recruiting
Montauban, France, 82000
Novartis Investigative Site Recruiting
Montpellier, France, 34000
Novartis Investigative Site Not yet recruiting
Nantes Cedex 1, France, 44093
Novartis Investigative Site Not yet recruiting
Nice, France, 06000
Novartis Investigative Site Not yet recruiting
Paris, France, 75007
Novartis Investigative Site Not yet recruiting
Saitnt Herblain, France, 44819
Novartis Investigative Site Not yet recruiting
Toulouse, France, 31077
Novartis Investigative Site Not yet recruiting
Tours, France, 37000
Novartis Investigative Site Not yet recruiting
Vannes, France, 56000
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: NCT01908816     History of Changes
Other Study ID Numbers: CRFB002GFR02
Study First Received: July 20, 2013
Last Updated: June 5, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Diabetes Complications
Diabetes Mellitus
Eye Diseases
Ocular Hypertension
Choroidal Neovascularization
Diabetic Retinopathy
Glaucoma, Neovascular
Macular Edema
Neovascularization, Pathologic
Cardiovascular Diseases
Choroid Diseases
Diabetic Angiopathies
Endocrine System Diseases
Glaucoma
Macular Degeneration
Metaplasia
Pathologic Processes
Retinal Degeneration
Retinal Diseases
Uveal Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014