Biswas 2011.
| Methods |
Number randomized (total and per group): 120 participants randomly assigned to study treatment: 60 in bevacizumab group and 60 in ranibizumab group Exclusions after randomization: none Number analyzed (total and per group): 104 total participants who completed 18 months of follow‐up: 50 in bevacizumab group and 54 in ranibizumab group Unit of analysis: individuals (1 study eye per participant) Losses to follow‐up: 16 participants by 18 months: reasons for losses to follow‐up not reported (10 in bevacizumab group, 6 in ranibizumab group) Compliance: 104/120 participants completed the 18‐month study Intention‐to‐treat analysis: no; 16 participants enrolled and randomized were not included in analysis Reported power calculation: no; "aimed to enroll a total of 120 patients...this number was arrived at by the investigators after considering the sample size of the available literature of relevant studies" Study design comment: see "Risk of bias" table regarding randomization logistics |
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| Participants |
Country: 2 study centers in Kolkata, India Age: not reported for 120 enrolled participants (mean 64.4 years in analyzed bevacizumab group; mean 63.5 years in analyzed ranibizumab group) Gender (per cent): not reported for 120 enrolled participants (28/50 [56%] men and 22/50 [44%] women in analyzed bevacizumab group; 22/54 [41%] men and 32/54 [59%] women in analyzed ranibizumab group) Inclusion criteria: age 50 years or older; presence of subfoveal or juxtafoveal CNV of any type; active leakage pattern; baseline BCVA between 35 and 70 ETDRS letters; baseline central macular thickness ≥ 250 μm, as measured by OCT Exclusion criteria: previous treatment for CNV in either eye; macular scarring; any coexisting other ocular disease or pathology; monocular patients; history of ocular surgery within 6 months of enrollment; history of cerebrovascular accident and myocardial infarction Equivalence of baseline characteristics: gender imbalance between analyzed groups Diagnoses in participants: all with subfoveal or juxtafoveal CNV; 22/50 participants with occult CNV in bevacizumab group and 24/54 participants with occult CNV in ranibizumab group |
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| Interventions |
Intervention 1: 1.25 mg intravitreal bevacizumab every month for first 3 months; retreatment afterward based on OCT or VA changes
Intervention 2: 0.5 mg intravitreal ranibizumab every month for first 3 months; retreatment afterward based on OCT or VA changes
Length of follow‐up Planned: 18 months Actual: 18 months |
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| Outcomes |
Primary outcomes, as defined: "changes in BCVA and CMT from baseline (month 0) to month 18"
Secondary outcomes, as reported: blood pressure measurements; reports of unusual extremity pain
Adverse events Intervals at which outcome assessed: monthly through 18 months |
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| Notes |
Trial registration: not reported Funding sources: reported "nil" Declarations of interest: "none declared" Study period: April 2007 to April 2009 Reported subgroup analyses: for participants with predominantly classic CNV Contacting study investigators: trial authors contacted; no additional information provided for this review |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Using random numbers tables, 60 numbers were randomly picked up from 1 to 120 and assigned to group A while the remaining sixty numbers were assigned to group B" |
| Allocation concealment (selection bias) | Unclear risk | "...randomization of the 120 numbers into two groups was done before initiation of enrolment itself. Upon initiation of enrollment, the patients were numbered sequentially based on the serial order of enrolment in the study. Depending on the enrolment number, the patients were automatically assigned to either group A or B based on the prior randomization of number 1‐120 into two equal groups using random number tables" |
| Masking of participants (performance bias) | Unclear risk | Masking of participants not reported |
| Masking of study personnel (performance bias) | Low risk | "The injections were given...by the investigators, who were blinded to the type of injection" |
| Masking of outcome assessment (detection bias) | Low risk | "All assessors were masked to the group of patients they were following up" |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Sixteen (13%) participants lost to follow‐up were excluded from analyses: 10 in the bevacizumab group and 6 in the ranibizumab group |
| Selective reporting (reporting bias) | Unclear risk | No protocol nor clinical trial registration was identified for this study. Outcomes were reported for stated outcomes in the Methods section of the published report; however, only P values were reported for between‐group comparisons, and no standard deviation or variance measures were reported for continuous outcomes |
| Other bias | Low risk | None observed |