Phase 3
Completed N=357
Ranibizumab Intravitreal Injections in Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion
Source: ClinicalTrials.gov NCT01535261 ↗Enrolled (actual)
357
Serious AEs
17.9%
Results posted
Jun 2016
Primary outcomePrimary: Mean Change in Best Corrected Visual Acuity (BCVA) at Month 12 Compared to Baseline — 12.3 Letters
◆ Published Evidence
Established
43citations · ~5 / year
Sustained Benefits from Ranibizumab for Central Retinal Vein Occlusion with Macular Edema: 24-Month Results of the CRYSTAL Study.
Summary
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.
Linked Publications (2)
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Sustained Benefits from Ranibizumab for Central Retinal Vein Occlusion with Macular Edema: 24-Month Results of the CRYSTAL Study.
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SYSTEMATIC CORRELATION OF CENTRAL SUBFIELD THICKNESS WITH RETINAL FLUID VOLUMES QUANTIFIED BY DEEP LEARNING IN THE MAJOR EXUDATIVE MACULAR DISEASES.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Best Corrected Visual Acuity (BCVA) at Month 12 Compared to Baseline |
12.3 | — |
| SECONDARY Mean Change in Best Corrected Visual Acuity (BCVA) at Month 24 Compared to Baseline |
12.1 | — |
| SECONDARY Mean Average Change in Best Corrected Visual Acuity (BCVA From Baseline Month 12 and Month 24 |
11.8; 12.1 | — |
| SECONDARY Mean Average Change in BCVA From First Treatment Interruption (Due to BCVA Stabilization) to Month 12 and Month 24 |
-2.7; -2.5 | — |
| SECONDARY Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 and Month 24 in the Study Eye |
296; 275; 227; 175; 32; 290 | — |
| SECONDARY Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 and Month 24 |
169; 161 | — |
| SECONDARY Mean Change in Central Reading Center (CRC)-Assessed Central Subfield Thickness (CSFT) From Month 12 and Month 24 Compared to Baseline |
-335.7; -349.1 | — |
| SECONDARY Mean Change in Patient-reported Outcomes in NEI-VFQ-25 Composite and Subscale Scores at Month 12 and Month 24 Compared to Baseline |
6.9; 6.6 | — |
Eligibility Criteria
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®])
Data sourced from ClinicalTrials.gov (NCT01535261) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.