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

July 2, 2019 updated by: Novartis Pharmaceuticals
The pupose of this study is to evaluate the safety and the efficacy of ranibizumab in rare VEGF driven ocular diseases.

Study Overview

Study Type

Interventional

Enrollment (Actual)

270

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Amiens Cedex 1, France, 80054
        • Novartis Investigative Site
      • Angers, France, 49044
        • Novartis Investigative Site
      • Bordeaux, France, 33000
        • Novartis Investigative Site
      • Bordeaux, France, 33100
        • Novartis Investigative Site
      • Caen, France, 14050
        • Novartis Investigative Site
      • Creteil, France, 94000
        • Novartis Investigative Site
      • Ecully, France, 69130
        • Novartis Investigative Site
      • Grenoble, France, 38043
        • Novartis Investigative Site
      • Grenoble, France, 38000
        • 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, 75006
        • Novartis Investigative Site
      • Paris, France, 75014
        • Novartis Investigative Site
      • Paris, France, 75013
        • Novartis Investigative Site
      • Paris, France, 75015
        • Novartis Investigative Site
      • Paris Cedex 19, France, 75940
        • Novartis Investigative Site
      • Paris cedex 10, France, 75010
        • 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, 37044
        • Novartis Investigative Site
      • Tours, France, 37000
        • Novartis Investigative Site
      • Vannes, France, 56000
        • Novartis Investigative Site
    • Seine Saint Denis
      • Bobigny cedex, Seine Saint Denis, France, 93009
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ranibizumab
0.5 mg ranibizumab applied in an individualized regimen as IVT injection of 0.05 mL.
One injection of Ranibizumab 0.5 mg and retreatment according to disease activity and/or visual impairment on an as needed regimen (PRN)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time Frame: 24 months
Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) for ocular and non-ocular events. Due to early termination, only descriptive analysis was conducted.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline Best Corrected Visual Acuity (BCVA) for Patients With Choroidal Neovascularization (CNV) and Macular Edema (ME)
Time Frame: 3 months, 12 months
BCVA change for diseases affecting the macular area either through CNV or ME. BCVA is tested using the ETDRS (Early Treatment Diabetic Retinopathy Study), the Snellen or Monoyer scales. The three scales are designed to measure visual acuity. ETDRS score is expressed in letter, Snellen and Monoyer score in fraction. BCVA assessment is presented in ETDRS after conversion if collected in Snellen or Monoyer. (Monoyer converted to Snellen = 2 x (Monoyer fraction) and Snellen converted to approximate ETDRS letters = 1x log(Snellen fraction). ETDRS letter score was transformed in logMAR unit for statistical analysis (- LogMAR = -(ETDRS-85)/50). The worse ETDRS letter score is 0 (logMAR 2.3) and the best ETDRS letter score is 100 (logMAR -0.3).
3 months, 12 months
Average Change of Neovascularization Extension for Patients With Neovascular Glaucoma
Time Frame: 3 month, 12 month

The extent of iris neovascularization was assessed by iris photography and graded using the "Teich and Walsh grading system". This grading system measures the number of quadrant at iris pupillary zone or iris ciliary zone where iris neovascularization (NV) is observed.

Grade 0 = "No iris vascularization", Grade 1= Less than 2 quadrants of NV at iris pupillary zone, Grade 2 = More than 2 quadrants of NV at iris pupillary zone, Grade 3 =Grade 2 + less than 3 quadrants of NV at iris ciliary zone and/or ectropion uveae; Grade 4 =More than 3 quadrants of NV at iris ciliary zone and/or ectropion uveae)

3 month, 12 month
Proportion of Patient With Vitreous Cavity Hemorrhage Occurrence for Patient With Proliferative Retinopathy
Time Frame: 3 months, 12 month
Occurrence of postoperative vitreous cavity hemorrhage
3 months, 12 month
Mean Change From Baseline in Change in Central Retinal Thickness for Patients With CNV (Choroidal Neovascularization) and ME (Macular Edema)"
Time Frame: 3 months, 12 month
CRT in micrometers assessed by Optical Tomography (OCT) at each single study visit. A reduction is thickness indicates an improvement is the lesion area
3 months, 12 month
Proportion of Patients With Angiographic Leakage
Time Frame: 3 months, 12 month
Angiography was taken via fluorescein angiography. Any increases of angiographic leakage was counted between baseline and month 3. Also any decreases of angiographic leakage was counted between baseline and 3 month.
3 months, 12 month
Ranibizumab Injection
Time Frame: 3 months, 12 month
Number of ranibizumab injections needed by decreased visual acuity and/or increasing retinal thickness in 3 months of observation period
3 months, 12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2013

Primary Completion (Actual)

January 8, 2016

Study Completion (Actual)

January 8, 2016

Study Registration Dates

First Submitted

July 20, 2013

First Submitted That Met QC Criteria

July 23, 2013

First Posted (Estimate)

July 26, 2013

Study Record Updates

Last Update Posted (Actual)

August 12, 2019

Last Update Submitted That Met QC Criteria

July 2, 2019

Last Verified

July 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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