Comparison of the long-term efficacy and safety of Lucentis versus Ozurdex in patients with visual impairment due to macular edema following retinal vein occlusion (central or branch vein) who have completed the respective core study (CRFB002EDE17 or CRFB002EDE18)

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) - COMRADE-XT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005045-13-DE

Enrollment

Unknown

Registered

2011-12-16

Start date

2012-04-26

Completion date

Unknown

Last updated

2014-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

visual impairment due to macular edema following retinal vein occlusion (branch or central) MedDRA version: 14.1 Level: LLT Classification code 10054467 Term: Macular edema System Organ Class: 10015919 - Eye disorders

Interventions

Trade Name: Lucentis Product Name: Lucentis Product Code: RFB002 Pharmaceutical Form: Solution for injection INN or Proposed INN: RANIBIZUMAB CAS Number: 347396-82-1 Current Sponsor code: RFB002 Other

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients must have completed the core study assessments at month 6 of study CRFB002EDE17 or CRFB002EDE18, respectively. 2. Signed Informed Consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 140

Exclusion criteria

Exclusion criteria: 1.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. 2. Current use or likely need of systemic medications known to be toxic to the lens, retina or optic nerve 3.History of hypersensitivity to Ranibizumab or Ozurdex or any component of the ranibizumab respectively Ozurdey formulation

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to evaluate the ocular and non-ocular adverse events during the 6-months study period in patients treated with Lucentis (0.5 mg) vs. treated with Ozurdex;Secondary Objective: • ocular and non-ocular adverse events over a cumulative 15-months period - including the core and extension study • mean average change of the best-corrected visual acuity (BCVA) assessed by ETDRS chart over the 6-months study period • 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 • mean change in central subfield thickness (CSFT) as assessed by OCT over the 6-months study period •mean change in central subfield thickness (CSFT)as assessed by OCT over 12-months study period- including the core and the extension study • 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 for both Lucentis PRN and Ozurdex ;Primary end point(s): Comparison of the long-term safety profiles of the two treatment arms. This will be achieved by the standard safety evaluations;Timepoint(s) of evaluation of this end point: 6 months	—

Measure

Time frame

Main Objective: The primary objective is to evaluate the ocular and non-ocular adverse events during the 6-months study period in patients treated with Lucentis (0.5 mg) vs. treated with Ozurdex;Secondary Objective: • ocular and non-ocular adverse events over a cumulative 15-months period - including the core and extension study • mean average change of the best-corrected visual acuity (BCVA) assessed by ETDRS chart over the 6-months study period • 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 • mean change in central subfield thickness (CSFT) as assessed by OCT over the 6-months study period •mean change in central subfield thickness (CSFT)as assessed by OCT over 12-months study period- including the core and the extension study • 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 for both Lucentis PRN and Ozurdex ;Primary end point(s): Comparison of the long-term safety profiles of the two treatment arms. This will be achieved by the standard safety evaluations;Timepoint(s) of evaluation of this end point: 6 months

—

Secondary

Measure	Time frame
Secondary end point(s): For the binary secondary endpoints (VA gain/loss = 15/10letters), the absolute and relative frequencies will be tabulated. For treatment comparisons, the difference in proportions and the Odds Ratio will be calculated with the respective confidence intervals and p-values. The time courses of BCVA changes will be displayed graphically (LS-means and treatment contrasts with confidence limits at each measurement time). Time to VA gain = 15 will be analyzed by the Kaplan-Maier-Method.;Timepoint(s) of evaluation of this end point: 6 months	—

Measure

Time frame

Secondary end point(s): For the binary secondary endpoints (VA gain/loss = 15/10letters), the absolute and relative frequencies will be tabulated. For treatment comparisons, the difference in proportions and the Odds Ratio will be calculated with the respective confidence intervals and p-values. The time courses of BCVA changes will be displayed graphically (LS-means and treatment contrasts with confidence limits at each measurement time). Time to VA gain = 15 will be analyzed by the Kaplan-Maier-Method.;Timepoint(s) of evaluation of this end point: 6 months

—

Countries

Germany

Contacts

Public ContactProject Leader

Novartis Pharma GmbH

thomas.knorr@novartis.com004991127313005

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026

Comparison of the long-term efficacy and safety of Lucentis versus Ozurdex in patients with visual impairment due to macular edema following retinal vein occlusion (central or branch vein) who have completed the respective core study (CRFB002EDE17 or CRFB002EDE18)

Conditions

Related papers

Interventions

Sponsors

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Contacts

Outcome results