- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01908816
An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases. (ECLIPSE)
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Amiens Cedex 1, France, 80054
- Novartis Investigative Site
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Angers, France, 49044
- Novartis Investigative Site
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Bordeaux, France, 33000
- Novartis Investigative Site
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Bordeaux, France, 33100
- Novartis Investigative Site
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Caen, France, 14050
- Novartis Investigative Site
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Creteil, France, 94000
- Novartis Investigative Site
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Ecully, France, 69130
- Novartis Investigative Site
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Grenoble, France, 38043
- Novartis Investigative Site
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Grenoble, France, 38000
- Novartis Investigative Site
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Lille, France, 59000
- Novartis Investigative Site
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Lyon, France, 69275
- Novartis Investigative Site
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Lyon Cedex 04, France, 69317
- Novartis Investigative Site
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Mantes la jolie, France, 78201
- Novartis Investigative Site
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Marseille, France, F 13008
- Novartis Investigative Site
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Marseille Cedex 8, France, 13008
- Novartis Investigative Site
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Melun, France, 77000
- Novartis Investigative Site
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Montauban, France, 82000
- Novartis Investigative Site
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Montpellier, France, 34000
- Novartis Investigative Site
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Mulhouse cedex, France, 68070
- Novartis Investigative Site
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Nantes Cedex 1, France, 44093
- Novartis Investigative Site
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Nice, France, 06000
- Novartis Investigative Site
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Paris, France, 75006
- Novartis Investigative Site
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Paris, France, 75014
- Novartis Investigative Site
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Paris, France, 75013
- Novartis Investigative Site
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Paris, France, 75015
- Novartis Investigative Site
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Paris Cedex 19, France, 75940
- Novartis Investigative Site
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Paris cedex 10, France, 75010
- Novartis Investigative Site
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Paris, Cedex 12, France, F-75571
- Novartis Investigative Site
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Poitiers, France, 86021
- Novartis Investigative Site
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Rouen, France, 76100
- Novartis Investigative Site
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Saint-Jean, France, 31240
- Novartis Investigative Site
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Saitnt Herblain, France, 44819
- Novartis Investigative Site
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St-Priest-en-Jarez, France, 42270
- Novartis Investigative Site
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Strasbourg Cedex, France, 67091
- Novartis Investigative Site
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Toulouse, France, 31077
- Novartis Investigative Site
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Tours, France, 37044
- Novartis Investigative Site
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Tours, France, 37000
- Novartis Investigative Site
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Vannes, France, 56000
- Novartis Investigative Site
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Seine Saint Denis
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Bobigny cedex, Seine Saint Denis, France, 93009
- Novartis Investigative Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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One injection of Ranibizumab 0.5 mg and retreatment according to disease activity and/or visual impairment on an as needed regimen (PRN)
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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
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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.
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24 months
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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
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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).
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3 months, 12 months
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Average Change of Neovascularization Extension for Patients With Neovascular Glaucoma
Time Frame: 3 month, 12 month
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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
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Proportion of Patient With Vitreous Cavity Hemorrhage Occurrence for Patient With Proliferative Retinopathy
Time Frame: 3 months, 12 month
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Occurrence of postoperative vitreous cavity hemorrhage
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3 months, 12 month
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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
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CRT in micrometers assessed by Optical Tomography (OCT) at each single study visit.
A reduction is thickness indicates an improvement is the lesion area
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3 months, 12 month
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Proportion of Patients With Angiographic Leakage
Time Frame: 3 months, 12 month
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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.
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3 months, 12 month
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Ranibizumab Injection
Time Frame: 3 months, 12 month
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Number of ranibizumab injections needed by decreased visual acuity and/or increasing retinal thickness in 3 months of observation period
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3 months, 12 month
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Endocrine System Diseases
- Ocular Hypertension
- Diabetic Angiopathies
- Diabetes Complications
- Diabetes Mellitus
- Retinal Degeneration
- Retinal Diseases
- Uveal Diseases
- Choroid Diseases
- Macular Degeneration
- Metaplasia
- Glaucoma
- Diabetic Retinopathy
- Macular Edema
- Choroidal Neovascularization
- Neovascularization, Pathologic
- Glaucoma, Neovascular
- Physiological Effects of Drugs
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Ranibizumab
Other Study ID Numbers
- CRFB002GFR02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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