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

Diabetic Retinopathy Clinical Trial

— ECLIPSE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01908816
• Other study ID #: CRFB002GFR02
• Status: Completed
• Phase: Phase 3
• Start date: September 26, 2013
• Est. completion date: January 8, 2016

Study information

• Verified date: July 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: January 8, 2016
• Est. primary completion date: January 8, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Diabetic Retinopathy
• Glaucoma, Neovascular
• Macular Edema
• Neovascularization, Pathologic

Intervention

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)

Locations

Country	Name	City	State
France	Novartis Investigative Site	Amiens Cedex 1
France	Novartis Investigative Site	Angers
France	Novartis Investigative Site	Bobigny cedex	Seine Saint Denis
France	Novartis Investigative Site	Bordeaux
France	Novartis Investigative Site	Bordeaux
France	Novartis Investigative Site	Caen
France	Novartis Investigative Site	Creteil
France	Novartis Investigative Site	Ecully
France	Novartis Investigative Site	Grenoble
France	Novartis Investigative Site	Grenoble
France	Novartis Investigative Site	Lille
France	Novartis Investigative Site	Lyon
France	Novartis Investigative Site	Lyon Cedex 04
France	Novartis Investigative Site	Mantes la jolie
France	Novartis Investigative Site	Marseille
France	Novartis Investigative Site	Marseille Cedex 8
France	Novartis Investigative Site	Melun
France	Novartis Investigative Site	Montauban
France	Novartis Investigative Site	Montpellier
France	Novartis Investigative Site	Mulhouse cedex
France	Novartis Investigative Site	Nantes Cedex 1
France	Novartis Investigative Site	Nice
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Paris cedex 10
France	Novartis Investigative Site	Paris Cedex 19
France	Novartis Investigative Site	Paris, Cedex 12
France	Novartis Investigative Site	Poitiers
France	Novartis Investigative Site	Rouen
France	Novartis Investigative Site	Saint-Jean
France	Novartis Investigative Site	Saitnt Herblain
France	Novartis Investigative Site	St-Priest-en-Jarez
France	Novartis Investigative Site	Strasbourg Cedex
France	Novartis Investigative Site	Toulouse
France	Novartis Investigative Site	Tours
France	Novartis Investigative Site	Tours
France	Novartis Investigative Site	Vannes

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 months
Secondary	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).	3 months, 12 months
Secondary	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)	3 month, 12 month
Secondary	Proportion of Patient With Vitreous Cavity Hemorrhage Occurrence for Patient With Proliferative Retinopathy	Occurrence of postoperative vitreous cavity hemorrhage	3 months, 12 month
Secondary	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	3 months, 12 month
Secondary	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.	3 months, 12 month
Secondary	Ranibizumab Injection	Number of ranibizumab injections needed by decreased visual acuity and/or increasing retinal thickness in 3 months of observation period	3 months, 12 month