Citations: Campochiaro PA, Brown DM, Awh CC, et al. Sustained Benefits from Ranibizumab for Macular Edema following Central Retinal Vein Occlusion: Twelve-Month Outcomes of a Phase III Study. Ophthalmology 2011;118:2041–2049
- CRUISE is a prospective study that evaluated the visual and anatomic outcomes of patients with macular edema secondary to central retinal vein occlusion (CRVO) who received either prompt monthly ranibizumab (0.3mg or 0.5mg) injections or sham injections for six months followed by a six month observation period during which all patients were eligible for monthly ranibizumab injections based on certain criteria.
- The treatment groups achieved significant gains in vision by six months and these were maintained at one year, with a mean BCVA letter score gain of 13.9 in both treatment groups.
- In the sham group, the mean gain in BCVA letter score was only 0.8 at six months. After the initiation of as needed monthly ranibizumab injections, there was an increase in BCVA letter score (mean 7.3), but it was not as substantial as the gains in the treatment groups.
- All groups had significant and relatively similar anatomic improvement as measured by a decrease in central foveal thickness (CFT) at month 12.
To assess the efficacy and safety of intravitreal ranibizumab injections (0.3 mg or 0.5 mg) in the treatment of macular edema secondary to CRVO.
Prospective, randomized, sham injection-controlled, double-masked, multicenter clinical trial.
- Initial enrollment criteria: 18 years or older, foveal involving macular edema due to CRVO diagnosed within 12 months of screening, BCVA of 20/40 - 20/320 and CFT 250µm or greater.
- Completion of the CRUISE 6 month study in which patients were randomized 1:1:1 to receive either 0.3 mg or 0.5 mg intravitreal injections of ranibizumab or sham injections on a monthlybasis during the initial study period (day 0 to month 5).
Major inclusion criteria:
RANDOMIZATION SCHEME AND INTERVENTIONS
After the initial 6 month study of strict monthly injections, all patients (study and control) were eligible for intravitreal ranibizumab injections if best corrected visual acuity (BCVA) was 20/40 or less or the mean CFT was 250µm or greater on OCT. Patients were examined on a monthly basis. The study patients who had received ranibizumab injections in the first half of the study would receive their previously established dose while patients previously in the sham group would receive 0.5mg of ranibizumab when eligible.
- There was a total of 392 patients that enrolled in the CRUISE trial and 349 completed the trail to 12 months: 109 patients in the sham/0.5mg ranibizumab group, 126 in the 0.3/0.3mg ranibizumab group, and 114 in the 0.5/0.5mg ranibizumab group.
- All three groups had similar demographics and ocular characteristics, including visual acuity and central foveal thickness, at baseline.
- 12 months starting from enrollment in the CRUISE trial.
Visual acuity end-points
- Mean change in BCVA letter score from baseline to month 6: 12.7, 14.9, and 0.8 in the 0.3 mg, 0.5 mg, and sham groups, respectively.
- Mean change in BCVA letter score from baseline to month 12: 13.9, 13.9, and 7.3 in the 0.3 mg, 0.5 mg, and sham/0.5 mg groups, respectively.
- Percentage of patients who improved by BCVA letter score of 15 or more at month 12: 47.0, 50.8 and 33.1 in the 0.3 mg, 0.5 mg, and sham/0.5 mg groups, respectively.
- Percentage of patients who experienced a decrease in BCVA letter score of 15 or more at month 12: 3.8, 2.3 and 10.0 in the 0.3 mg, 0.5 mg, and sham/0.5 mg groups, respectively.
- Percentage of patients with a Snellen BCVA of 20/40 or better at month 12: 43.2, 43.1 and 34.6 in the 0.3 mg, 0.5 mg, and sham/0.5 mg groups, respectively.
- Proportion of patients with a Snellen BCVA of 20/200 or worse at month 12: 12.1, 12.3 and 20.0 in the 0.3 mg, 0.5 mg, and sham/0.5 mg groups, respectively.
- The average number of as-needed ranibizumab injections between months 6 and 12 was 3.9, 3.6, and 4.2 in the 0.3 mg, 0.5 mg, and sham/0.5 mg groups respectively.
- The percentage of patients who did not receive any injections between months 6 and 12 was 7.0, 6.7, and 4.3 in the 0.3 mg, 0.5 mg, and sham/0.5 mg groups respectively.
- Mean decrease of CFT from baseline to month 12: 452.8µm, 462.1µm, 427.2µm in the 0.3 mg, 0.5 mg, and sham/0.5 mg groups, respectively.
- Percentage of patients with CFT less than or equal to 250µm: 75.8, 77.7, 70.8 in the 0.3 mg, 0.5 mg, and sham/0.5 mg groups respectively.
- There were low rates of ocular and non-ocular adverse events in all groups.
- In this prospective study, early aggressive treatment followed by as needed monthly injections of ranibizumab for macular edema in CRVO resulted in substantial vision and anatomic gains that were maintained up to 12 months. Although the initiation of as-needed injections in the sham group at six months resulted in similar anatomic outcomes, the visual gains were not nearly as substantial as in the treatment groups, suggesting that delaying treatment may compromise gains in visual acuity.