Ranibizumab Intravitreal Injections in Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion (CRYSTAL)

Novartis

Status and phase

Completed

Phase 3

Conditions

Macular Edema

Central Retinal Vein Occlusion

Treatments

Drug: Ranibizumab 0.5 mg/0.05 ml

Study type

Interventional

Funder types

Industry

Identifiers

NCT01535261

2011-002350-31 (EudraCT Number)

CRFB002E2401

Details and patient eligibility

About

The present study provided additional efficacy and safety data for 0.5-mg ranibizumab using as needed (PRN) dosing over 24 months in patients with visual impairment due to macular edema secondary to Central Retinal Vein Occlusion (CRVO). Spectral domain high-definition optical coherence tomography (OCT) images was analyzed to gain insights into predictive factors for disease progression and the possibility of reduced monitoring was assessed in Year 2. The results of this open-label study provided long-term safety and efficacy data to further guide recommendations on the use of ranibizumab in this indication.

Enrollment

357 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female patients ≥ 18 years of age
Diagnosis of visual impairment exclusively due to ME secondary to CRVO
BCVA score at Screening and Baseline between 73 and 19 letters Early Treatment Diabetic Retinopathy Study (ETDRS), inclusively (approximate Snellen chart equivalent of 20/40 and 20/400)

Exclusion criteria

Uncontrolled blood pressure defined as systolic value of > 160 mm Hg or diastolic value of > 100 mm Hg at Screening or Baseline.
Any active periocular or ocular infection or inflammation at Screening or Baseline in either eye
Uncontrolled glaucoma at Screening or Baseline or diagnosed within 6 months before Baseline in either eye
Use of any systemic antivascular endothelial growth factor (anti-VEGF) drugs within 6 months before Baseline (eg, sorafenib [Nexavar®], sunitinib [Sutent®], bevacizumab [Avastin®])