Clinical trial NCT01908816: An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases.
Official title: An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Choroidal Neovascularization
Macular Edema
Glaucoma, Neovascular
Diabetic Retinopathy
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-07-26
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: 24 months
Secondary outcomes:
measure: Change From Baseline Best Corrected Visual Acuity (BCVA) for Patients With Choroidal Neovascularization (CNV) and Macular Edema (ME)
timeFrame: 3 months, 12 months
measure: Average Change of Neovascularization Extension for Patients With Neovascular Glaucoma
timeFrame: 3 month, 12 month
measure: Proportion of Patient With Vitreous Cavity Hemorrhage Occurrence for Patient With Proliferative Retinopathy
timeFrame: 3 months, 12 month
measure: Mean Change From Baseline in Change in Central Retinal Thickness for Patients With CNV (Choroidal Neovascularization) and ME (Macular Edema)"
timeFrame: 3 months, 12 month
measure: Proportion of Patients With Angiographic Leakage
timeFrame: 3 months, 12 month
measure: Ranibizumab Injection
timeFrame: 3 months, 12 month
Other outcomes:
Locations:
city: Bobigny cedex
country: France
facility: Novartis Investigative Site
state: Seine Saint Denis
city: Amiens Cedex 1
country: France
facility: Novartis Investigative Site
city: Angers
country: France
facility: Novartis Investigative Site
city: Bordeaux
country: France
facility: Novartis Investigative Site
city: Bordeaux
country: France
facility: Novartis Investigative Site
city: Caen
country: France
facility: Novartis Investigative Site
city: Creteil
country: France
facility: Novartis Investigative Site
city: Ecully
country: France
facility: Novartis Investigative Site
city: Grenoble
country: France
facility: Novartis Investigative Site
city: Grenoble
country: France
facility: Novartis Investigative Site
city: Lille
country: France
facility: Novartis Investigative Site
city: Lyon Cedex 04
country: France
facility: Novartis Investigative Site
city: Lyon
country: France
facility: Novartis Investigative Site
city: Mantes la jolie
country: France
facility: Novartis Investigative Site
city: Marseille Cedex 8
country: France
facility: Novartis Investigative Site
city: Marseille
country: France
facility: Novartis Investigative Site
city: Melun
country: France
facility: Novartis Investigative Site
city: Montauban
country: France
facility: Novartis Investigative Site
city: Montpellier
country: France
facility: Novartis Investigative Site
city: Mulhouse cedex
country: France
facility: Novartis Investigative Site
city: Nantes Cedex 1
country: France
facility: Novartis Investigative Site
city: Nice
country: France
facility: Novartis Investigative Site
city: Paris cedex 10
country: France
facility: Novartis Investigative Site
city: Paris Cedex 19
country: France
facility: Novartis Investigative Site
city: Paris, Cedex 12
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Poitiers
country: France
facility: Novartis Investigative Site
city: Rouen
country: France
facility: Novartis Investigative Site
city: Saint-Jean
country: France
facility: Novartis Investigative Site
city: Saitnt Herblain
country: France
facility: Novartis Investigative Site
city: St-Priest-en-Jarez
country: France
facility: Novartis Investigative Site
city: Strasbourg Cedex
country: France
facility: Novartis Investigative Site
city: Toulouse
country: France
facility: Novartis Investigative Site
city: Tours
country: France
facility: Novartis Investigative Site
city: Tours
country: France
facility: Novartis Investigative Site
city: Vannes
country: France
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: