Extension Study to Compare Long-term Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With RVO

Retinal Vein Occlusion Clinical Trial

Official title:

An Open-label, Multi-center, 6-month Extension Study Comparing the Long-term Efficacy and Safety of Lucentis (Ranibizumab) Intravitreal Injections Versus Ozurdex (Dexamethasone) Intravitreal Implant in Patients With Visual Impairment Due to Macular Edema Following Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO) Who Have Completed the Respective Core Study (CRFB002EDE17 or CRFB002EDE18)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01580020
• Other study ID #: CRFB002EDE20
• Status: Completed
• Phase: Phase 4
• First received: April 16, 2012
• Last updated: January 13, 2015
• Start date: May 2012
• Est. completion date: October 2014

Study information

• Verified date: January 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial Summary

The study is intended to characterize the clinical benefit regarding safety and efficacy of a long term treatment with Lucentis in comparison with Ozurdex over an additional 6 months and a 3-month follow-up period, following the initial 6-month treatment in the respective core studies CRFB002EDE17 and CRFB002EDE18.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must have completed the core study assessments at month 6 of study CRFB002EDE17 or CRFB002EDE18, respectively

Exclusion Criteria:

• Patients who experienced an uncontrollable rise in IOP during the core study CRFB002EDE17 respectively CRFB002EDE18, i.e. IOP could not be decreased to a stable level of < 25mmHg.

• Use of other investigational drugs

• Current use or likely need of systemic medications known to be toxic to the lens, retina or optic nerve

• History of hypersensitivity to Ranibizumab or Ozurdex or any component of the ranibizumab respectively Ozurdey formulation

• Any type of advanced, severe or unstable disease or its treatment, that could interfere with evaluations or put the patient at special risk

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Retinal Vein Occlusion

Intervention

Biological:
• RFB002

Drug:
• Dexamethasone
Ozurdex (Dexamethasone): intravitreal implant as per commercial label (700 µg Dexamethasone;

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Augsburg
Germany	Novartis Investigative Site	Bad Rothenfelde
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Bremen
Germany	Novartis Investigative Site	Chemnitz
Germany	Novartis Investigative Site	Darmstadt
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Duesseldorf
Germany	Novartis Investigative Site	Düsseldorf
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Freiburg i. Br
Germany	Novartis Investigative Site	Glauchau
Germany	Novartis Investigative Site	Göttingen
Germany	Novartis Investigative Site	Halle
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Ingolstadt
Germany	Novartis Investigative Site	Karlsruhe
Germany	Novartis Investigative Site	Karlsruhe
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Ludwigshafen
Germany	Novartis Investigative Site	Marburg
Germany	Novartis Investigative Site	Minden
Germany	Novartis Investigative Site	Muelheim
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	München
Germany	Novartis Investigative Site	München
Germany	Novartis Investigative Site	Recklinghausen
Germany	Novartis Investigative Site	Regensburg
Germany	Novartis Investigative Site	Sulzbach
Germany	Novartis Investigative Site	Tübingen
Germany	Novartis Investigative Site	Ulm
Germany	Novartis Investigative Site	Wolfsburg
Germany	Novartis Investigative Site	Wuerzburg

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collection of all ocular and non-ocular adverse events	Safety assessments will consist of monitoring and recording of all adverse events (AEs) and serious adverse events (SAEs), ophthalmic examinations, evaluation of cataract formation, intraocular pressure by tonometry, vital signs, and routine laboratory parameters.	6 months	Yes
Secondary	Collection of ocular and non-ocular adverse events of both treatment arms	• To describe and compare the ocular and non-ocular adverse events over a cumulative 15-months period - including the core and extension study - in patients treated with Lucentis vs. Ozurdex	15 months	No
Secondary	Mean average change of best corrected visual acuity	• To compare the mean average change of the best-corrected visual acuity (BCVA) assessed by ETDRS chart over the 6-months study period in patients treated with Lucentis vs. Ozurdex	6 months	No
Secondary	Mean average change of best corrected visual acuity	+ To compare the mean average change of the best-corrected visual acuity (BCVA) assessed by ETDRS chart over 12-months study period- including the core and the extension study in patients treated with Lucentis. Ozurdex	12 months	No
Secondary	Mean change in central subfield thickness	• To compare the mean change in central subfield thickness (CSFT) as assessed by OCT over the 6-months study period in patients treated with Lucentis vs. Ozurdex	6 months	No
Secondary	Mean change in central subfield thickness	• To compare the mean change in central subfield thickness (CSFT) as assessed by OCT over the 12-months study period in patients treated with Lucentis vs. Ozurdex	12 months	No
Secondary	Change of patients´ Quality of Life	• To compare changes in the quality of life according to NEI-VFQ 25, SF36 and EQ-5D questionnaires under treatment of ranibizumab versus Ozurdex® from Baseline to Month 6	6 months	No
Secondary	Time to the first retreatment and the total number of treatments of both treatment arms	• To evaluate the time to the first retreatment and the total number of treatments for both Lucentis PRN and Ozurdex	6 months	No