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

This study is currently recruiting participants.
Verified January 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01580020
First received: April 16, 2012
Last updated: January 21, 2014
Last verified: January 2014

April 16, 2012
January 21, 2014
May 2012
November 2014   (final data collection date for primary outcome measure)
Collection of all ocular and non-ocular adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01580020 on ClinicalTrials.gov Archive Site
  • Collection of ocular and non-ocular adverse events of both treatment arms [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    • 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
  • Mean average change of best corrected visual acuity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    • 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
  • Mean average change of best corrected visual acuity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    + 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
  • Mean change in central subfield thickness [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    • 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
  • Mean change in central subfield thickness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    • 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
  • Change of patients´ Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    • 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
  • Time to the first retreatment and the total number of treatments of both treatment arms [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    • To evaluate the time to the first retreatment and the total number of treatments for both Lucentis PRN and Ozurdex
  • Collection of ocular and non-ocular adverse events of both treatment arms [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    • 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
  • Mean average change of best corrected visual acuity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    • 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
  • Mean average change of best corrected visual acuity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    + 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 Lucentisvs. Ozurdex
  • Mean change in central subfield thickness [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    • 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
  • Mean change in central subfield thickness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    • 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
  • Change of patients´ Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    • 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
  • Time to the first retreatment and the total number of treatments of both treatment arms [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    • To evaluate the time to the first retreatment and the total number of treatments for both Lucentis PRN and Ozurdex
Not Provided
Not Provided
 
Extension Study to Compare Long-term Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With RVO
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)

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Retinal Vein Occlusion
  • Biological: RFB002
  • Drug: Dexamethasone
    Ozurdex (Dexamethasone): intravitreal implant as per commercial label (700 µg Dexamethasone;
  • Experimental: Arm A

    The PRN injection scheme applied in the core study will also be followed during this extension study:

    Patients should be monitored monthly (starting at V1E) for VA and treatment is to be resumed when monitoring indicates loss of VA due to disease activity. Monthly injections should then be administered until stable VA is reached again for 3 consecutive monthly assessments (implying a minimum of 2 injections during stable VA). The interval between 2 doses should not be shorter than 1 month

    Intervention: Biological: RFB002
  • Active Comparator: Arm B
    A PRN re-treatment scheme will be applied for the Ozurdex arm during this extension study, i.e. patients may receive an implant at V1E or later as needed: Patients should be monitored monthly and if there is a decline from stable VA stability due to macular edema patients will receive another intravitreal implant. (700 µg; long acting release (LAR)) given that in the opinion of the investigator the patient would benefit from the re-treatment. However, a minimum period of 5 months in between implantations is required.
    Intervention: Drug: Dexamethasone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
November 2014
November 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals
Germany
 
NCT01580020
CRFB002EDE20
No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP