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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01908816
Other study ID # CRFB002GFR02
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


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
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