Ranibizumab treatment of visual impairment caused by occluded vessels (veins) that lead to swelling of the retina in the back of the eye

A 24-month, phase IIIb, open-label, single arm, multicenter study assessing the efficacy and safety of an individualized, stabilization criteria-driven PRN dosing regimen with 0.5-mg ranibizumab intravitreal injections applied as monotherapy in patients with visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO) - CRYSTAL

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002350-31-GB

Enrollment

350

Registered

2011-11-02

Start date

2012-02-24

Completion date

Unknown

Last updated

2015-08-04

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 secondary to central retinal vein occlusion (CRVO) MedDRA version: 14.1 Level: LLT Classification code 10007972 Term: Central retinal vein occlusion System Organ Class: 10015919 - Eye disorders MedDRA version: 14.1 Level: PT Classification code 10025415 Term: Macular oedema System Organ Class: 10015919 - Eye disorders MedDRA version: 14.1 Level: PT Classification code 10047571 Term: Visual impairment System Organ Class: 10015919 - Eye disorders

Interventions

Trade Name: LUCENTIS Product Name: LUCENTIS Product Code: RFB002E Pharmaceutical Form: Solution for injection INN or Proposed INN: RANIBIZUMAB CAS Number: 347396-82-1 Current Sponsor code: RFBOO2 Othe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Written informed consent must be obtained before any study assessment is performed- Male or female patients must be at least 18 years of age - Diagnosis of visual impairment exclusively due to ME secondary to central retinal vein occlusion (CRVO) - Best-corrected visual acuity at Screening and Baseline must be between 73 and 19 letters Early Treatment Diabetic Retinopathy Study (ETDRS), inclusively (approximate Snellen chart equivalent of 20/40 and 20/400) Other protocol-defined inclusion criteria may apply 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test • Stroke or myocardial infarction less than 3 months prior to Screening • Uncontrolled blood pressure defined as systolic value of >160 mm Hg or diastolic value of >100 mm Hg at Screening or Baseline. Antihypertensive treatment can be initiated and has to be taken for at least 30 days after which the patient can be assessed for study eligibility a second time • Any active periocular or ocular infection or inflammation (eg, blepharitis, conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) at Screening or Baseline in either eye • Uncontrolled glaucoma (intraocular pressure [IOP] =30 mm Hg on medication or according to investigator’s judgment) at Screening or Baseline or diagnosed within 6 months prior to Baseline in either eye • Neovascularization of the iris or neovascular glaucoma in either eye • Use of any systemic anti-vascular endothelial growth factor (VEGF) drugs within 6 months prior to Baseline (eg, sorafenib [Nexavar®], sunitinib [Sutent®], bevacizumab [Avastin®]) • Prior treatment with any anti-angiogenic drugs (including any anti-VEGF agents) within 3 months prior to Baseline in either eye (eg, pegaptanib [Macugen®], ranibizumab [Lucentis®], bevacizumab [Avastin®]) • Panretinal laser photocoagulation within 3 months prior to Baseline or anticipated or scheduled within the next 3 months following Baseline in the study eye • Focal or grid laser photocoagulation within 4 months prior to Baseline in the study eye • Use of intra- or periocular corticosteroids (including sub-Tenon) within 3 months prior to Screening in the study eye • Any use of intraocular corticosteroid implants (eg, dexamethasone [Ozurdex®], fluocinolone acetonide [Iluvien®]) in the study eye Other protocol-defined exclusion criteria may apply

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to evaluate the efficacy of an individualized stabilization criteria-driven PRN dosing regimen with 0.5 mg ranibizumab as assessed by the mean BCVA change at Month 12 compared to Baseline.;Secondary Objective: To evaluate the efficacy of PRN dosing of 0.5-mg ranibizumab injections as assessed by: • the mean change in BCVA • the mean average change in BCVA • the proportion of patients achieving: - BCVA improvement of =1, =5, =10, =15, and =30 letters - reaching BCVA values of =73 letters (approximate 20/40 Snellen chart equivalent) - with a BCVA loss of <15 letters • the mean change in central reading center (CRC)-assessed central subfield thickness (CSFT) • the patient-reported outcomes by the NEI-VFQ-25 composite score and subscales To evaluate the mean average change in BCVA from the timepoint of the first treatment interruption (if due to BCVA stabilization) To evaluate the mean change in BCVA by visit from the timepoint of the first treatment interruption (if due to BCVA stabilization) To evaluate the safety of ranibizumab injections as assessed by the type, frequency, and severity of ocular and non-ocular AEs;Primary end point(s): The primary efficacy variable is the mean change in BCVA at Month 12 compared to Baseline.;Timepoint(s) of evaluation of this end point: at Month 12 compared to Baseline.	—

Measure

Time frame

Main Objective: The primary objective is to evaluate the efficacy of an individualized stabilization criteria-driven PRN dosing regimen with 0.5 mg ranibizumab as assessed by the mean BCVA change at Month 12 compared to Baseline.;Secondary Objective: To evaluate the efficacy of PRN dosing of 0.5-mg ranibizumab injections as assessed by: • the mean change in BCVA • the mean average change in BCVA • the proportion of patients achieving: - BCVA improvement of =1, =5, =10, =15, and =30 letters - reaching BCVA values of =73 letters (approximate 20/40 Snellen chart equivalent) - with a BCVA loss of <15 letters • the mean change in central reading center (CRC)-assessed central subfield thickness (CSFT) • the patient-reported outcomes by the NEI-VFQ-25 composite score and subscales To evaluate the mean average change in BCVA from the timepoint of the first treatment interruption (if due to BCVA stabilization) To evaluate the mean change in BCVA by visit from the timepoint of the first treatment interruption (if due to BCVA stabilization) To evaluate the safety of ranibizumab injections as assessed by the type, frequency, and severity of ocular and non-ocular AEs;Primary end point(s): The primary efficacy variable is the mean change in BCVA at Month 12 compared to Baseline.;Timepoint(s) of evaluation of this end point: at Month 12 compared to Baseline.

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Secondary

Measure	Time frame
Secondary end point(s): The following secondary efficacy endpoints will be evaluated for the study eye: • the mean change in BCVA from Month 1 through Month 24 compared to Baseline, by visit • the mean change in BCVA from Month the timepoint of the first treatment interruption (due to BCVA stabilization) through Month 24, by visit • the mean average change in BCVA from Month 1 through Month 12 and from Month 1 through Month 24 compared to Baseline • the mean average change in BCVA from the timepoint of the first treatment interruption (due to BCVA stabilization) through Month 12 and/or Month 24 • the number and proportion of patients with a BCVA improvement of =1, =5, =10, =15, and =30 letters from Baseline to Month 12 and Month 24, by visit • the number and proportion of patients with a BCVA value of =73 letters (approximate 20/40 Snellen chart equivalent) at Month 12 and Month 24, by visit • the number and proportion of patients with a BCVA loss of <15 letters from Baseline up to Month 12 and Month 24, by visit • the mean change in CRC-assessed CSFT from Month 1 through Month 12 and Month 24 compared to Baseline • the mean change in patient-reported outcomes in NEI-VFQ-25 score (composite score and subscales) at Month 12 and Month 24 compared to Baseline;Timepoint(s) of evaluation of this end point: from Month 1 through Month 12 and from Month 1 through Month 24 compared to Baseline	—

Measure

Time frame

Secondary end point(s): The following secondary efficacy endpoints will be evaluated for the study eye: • the mean change in BCVA from Month 1 through Month 24 compared to Baseline, by visit • the mean change in BCVA from Month the timepoint of the first treatment interruption (due to BCVA stabilization) through Month 24, by visit • the mean average change in BCVA from Month 1 through Month 12 and from Month 1 through Month 24 compared to Baseline • the mean average change in BCVA from the timepoint of the first treatment interruption (due to BCVA stabilization) through Month 12 and/or Month 24 • the number and proportion of patients with a BCVA improvement of =1, =5, =10, =15, and =30 letters from Baseline to Month 12 and Month 24, by visit • the number and proportion of patients with a BCVA value of =73 letters (approximate 20/40 Snellen chart equivalent) at Month 12 and Month 24, by visit • the number and proportion of patients with a BCVA loss of <15 letters from Baseline up to Month 12 and Month 24, by visit • the mean change in CRC-assessed CSFT from Month 1 through Month 12 and Month 24 compared to Baseline • the mean change in patient-reported outcomes in NEI-VFQ-25 score (composite score and subscales) at Month 12 and Month 24 compared to Baseline;Timepoint(s) of evaluation of this end point: from Month 1 through Month 12 and from Month 1 through Month 24 compared to Baseline

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Countries

Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Greece, Hungary, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Slovakia, Spain, Sweden, Switzerland, Turkey, United Kingdom

Outcome results

None listed

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