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

Primary Purpose

Choroidal Neovascularization, Macular Edema, Glaucoma, Neovascular

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
ranibizumab
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Choroidal Neovascularization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ranibizumab

Arm Description

0.5 mg ranibizumab applied in an individualized regimen as IVT injection of 0.05 mL.

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events as a Measure of Safety and Tolerability
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.

Secondary Outcome Measures

Change From Baseline Best Corrected Visual Acuity (BCVA) for Patients With Choroidal Neovascularization (CNV) and Macular Edema (ME)
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).
Average Change of Neovascularization Extension for Patients With Neovascular Glaucoma
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)
Proportion of Patient With Vitreous Cavity Hemorrhage Occurrence for Patient With Proliferative Retinopathy
Occurrence of postoperative vitreous cavity hemorrhage
Mean Change From Baseline in Change in Central Retinal Thickness for Patients With CNV (Choroidal Neovascularization) and ME (Macular Edema)"
CRT in micrometers assessed by Optical Tomography (OCT) at each single study visit. A reduction is thickness indicates an improvement is the lesion area
Proportion of Patients With Angiographic Leakage
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.
Ranibizumab Injection
Number of ranibizumab injections needed by decreased visual acuity and/or increasing retinal thickness in 3 months of observation period

Full Information

First Posted
July 20, 2013
Last Updated
July 2, 2019
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01908816
Brief Title
An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases.
Acronym
ECLIPSE
Official Title
An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 26, 2013 (Actual)
Primary Completion Date
January 8, 2016 (Actual)
Study Completion Date
January 8, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The pupose of this study is to evaluate the safety and the efficacy of ranibizumab in rare VEGF driven ocular diseases.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choroidal Neovascularization, Macular Edema, Glaucoma, Neovascular, Diabetic Retinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ranibizumab
Arm Type
Experimental
Arm Description
0.5 mg ranibizumab applied in an individualized regimen as IVT injection of 0.05 mL.
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Intervention Description
One injection of Ranibizumab 0.5 mg and retreatment according to disease activity and/or visual impairment on an as needed regimen (PRN)
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Change From Baseline Best Corrected Visual Acuity (BCVA) for Patients With Choroidal Neovascularization (CNV) and Macular Edema (ME)
Description
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).
Time Frame
3 months, 12 months
Title
Average Change of Neovascularization Extension for Patients With Neovascular Glaucoma
Description
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)
Time Frame
3 month, 12 month
Title
Proportion of Patient With Vitreous Cavity Hemorrhage Occurrence for Patient With Proliferative Retinopathy
Description
Occurrence of postoperative vitreous cavity hemorrhage
Time Frame
3 months, 12 month
Title
Mean Change From Baseline in Change in Central Retinal Thickness for Patients With CNV (Choroidal Neovascularization) and ME (Macular Edema)"
Description
CRT in micrometers assessed by Optical Tomography (OCT) at each single study visit. A reduction is thickness indicates an improvement is the lesion area
Time Frame
3 months, 12 month
Title
Proportion of Patients With Angiographic Leakage
Description
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.
Time Frame
3 months, 12 month
Title
Ranibizumab Injection
Description
Number of ranibizumab injections needed by decreased visual acuity and/or increasing retinal thickness in 3 months of observation period
Time Frame
3 months, 12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Bobigny cedex
State/Province
Seine Saint Denis
ZIP/Postal Code
93009
Country
France
Facility Name
Novartis Investigative Site
City
Amiens Cedex 1
ZIP/Postal Code
80054
Country
France
Facility Name
Novartis Investigative Site
City
Angers
ZIP/Postal Code
49044
Country
France
Facility Name
Novartis Investigative Site
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Novartis Investigative Site
City
Bordeaux
ZIP/Postal Code
33100
Country
France
Facility Name
Novartis Investigative Site
City
Caen
ZIP/Postal Code
14050
Country
France
Facility Name
Novartis Investigative Site
City
Creteil
ZIP/Postal Code
94000
Country
France
Facility Name
Novartis Investigative Site
City
Ecully
ZIP/Postal Code
69130
Country
France
Facility Name
Novartis Investigative Site
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
Novartis Investigative Site
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Novartis Investigative Site
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Novartis Investigative Site
City
Lyon Cedex 04
ZIP/Postal Code
69317
Country
France
Facility Name
Novartis Investigative Site
City
Lyon
ZIP/Postal Code
69275
Country
France
Facility Name
Novartis Investigative Site
City
Mantes la jolie
ZIP/Postal Code
78201
Country
France
Facility Name
Novartis Investigative Site
City
Marseille Cedex 8
ZIP/Postal Code
13008
Country
France
Facility Name
Novartis Investigative Site
City
Marseille
ZIP/Postal Code
F 13008
Country
France
Facility Name
Novartis Investigative Site
City
Melun
ZIP/Postal Code
77000
Country
France
Facility Name
Novartis Investigative Site
City
Montauban
ZIP/Postal Code
82000
Country
France
Facility Name
Novartis Investigative Site
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
Novartis Investigative Site
City
Mulhouse cedex
ZIP/Postal Code
68070
Country
France
Facility Name
Novartis Investigative Site
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Novartis Investigative Site
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
Novartis Investigative Site
City
Paris cedex 10
ZIP/Postal Code
75010
Country
France
Facility Name
Novartis Investigative Site
City
Paris Cedex 19
ZIP/Postal Code
75940
Country
France
Facility Name
Novartis Investigative Site
City
Paris, Cedex 12
ZIP/Postal Code
F-75571
Country
France
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75006
Country
France
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Novartis Investigative Site
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Novartis Investigative Site
City
Rouen
ZIP/Postal Code
76100
Country
France
Facility Name
Novartis Investigative Site
City
Saint-Jean
ZIP/Postal Code
31240
Country
France
Facility Name
Novartis Investigative Site
City
Saitnt Herblain
ZIP/Postal Code
44819
Country
France
Facility Name
Novartis Investigative Site
City
St-Priest-en-Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
Novartis Investigative Site
City
Strasbourg Cedex
ZIP/Postal Code
67091
Country
France
Facility Name
Novartis Investigative Site
City
Toulouse
ZIP/Postal Code
31077
Country
France
Facility Name
Novartis Investigative Site
City
Tours
ZIP/Postal Code
37000
Country
France
Facility Name
Novartis Investigative Site
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Novartis Investigative Site
City
Vannes
ZIP/Postal Code
56000
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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