Table 2.
Study quality
| Study (author and year) | Adequate sequence generation | Allocation concealment | Masking | Incomplete outcome data addressed | Free of selective reporting | Free of other bias (eg, similarity at baseline, power assessment) | Funder |
|---|---|---|---|---|---|---|---|
| Anti-VEGFs | |||||||
| Ranibizumab | |||||||
| READ-2 Study28 47 | Unclear | Unclear | Unclear | Yes (91.3% completion) | Yes | Comparison groups similar at baseline; power analysis not mentioned | Juvenile Diabetes Research Foundation, Genentech Inc |
| RESOLVE Study (Massin et al)36 | Yes | Yes | Yes (patients and outcome assessors) | Yes (82% completion in sham arm, 90.2% with ranibizumab) | Yes | Comparison groups similar at baseline; power analysis unclear | Novartis Pharma, Switzerland |
| RESTORE Study (Mitchell et al)24 | Yes | Unclear | Yes (patients, outcome assessors) | Yes (87.3–88.3% completion) | Yes | Comparison groups similar at baseline; power analysis carried out (power adequate for VA changes) | Novartis Pharma, Switzerland |
| RISE and RIDE (Nguyen et al)38 | Yes | Yes | Yes (patients, treating physician masked to assigned dose of ranibizumab) | Yes (2 year study completed by 83.3% of patients in RISE and by 84.6% in RIDE) | Yes | Comparison groups similar at baseline; ITT analysis; power analysis carried out (power adequate for primary endpoint) | Genentech Inc |
| Bevacizumab | |||||||
| BOLT Study (Michaelides et al)23 52 | Yes | Unclear | Partial (outcome assessors, not patients) | Yes (97.5% completion) | Yes | Comparison groups similar at baseline (except laser group had longer duration of clinically significant DMO); power analysis carried out (power adequate for VA changes) | Moorfields Special Trustees, National Institute for Health Research |
| Faghihi et al53 | Yes | Unclear | Yes (patient | Yes (100% completion) | Yes | Comparable groups at baseline | Not specified |
| Lam et al35 | Yes | Yes | Yes (patients and technicians assessing BCVA, OCT and IOP) | Yes (92.3% follow-up at 6 months) | Yes | Comparison groups similar at baseline; power analysis carried out (power adequate for CMT changes) | Supported in part by the Action for Vision Eye Foundation Hong Kong (charity) |
| Pegaptanib | |||||||
| Cunningham et al/Adamis et al39 57 | Yes | Unclear | Yes (patients and outcome assessors) | Yes (95% completion) | Yes | Comparison groups similar at baseline; acknowledge lack of power to detect differences between doses of pegaptanib | Eyetech Pharmaceuticals Inc, New York, and Pfizer Inc, New York |
| Sultan et al40 | Yes | Unclear | Yes (patients and outcome assessors) | Yes (69.9–73.8% completion) | Yes | Comparison groups similar at baseline; power analysis carried out (power adequate for VA changes) | Pfizer Inc, New York |
| Aflibercept | |||||||
| Da Vinci et al30 58 | Unclear (predetermined randomisation scheme) | Unclear | Yes (patients) | Yes (85% completion) | Yes | Comparison groups similar at baseline, power calculation completed | Regeneron Pharmaceuticals, Inc, New York |
| Steroids | |||||||
| Dexamethasone | |||||||
| Haller et al59 | Yes | Unclear | Yes (patients to dexamethasone dose, outcome assessors) | Yes (92% completion) | Yes | Comparison groups similar at baseline; power analysis carried out, but study not powered to detect differences in subgroups | Oculex Pharmaceuticals Inc |
| Fluocinolone | |||||||
| FAME Study (Campochiaro et al)29 60 | Unclear | Unclear | Partial (patients, masking of outcome assessment not mentioned) | Yes (drop-out rate 19.0–22.7%) | Yes | Comparison groups similar at baseline; power analysis not mentioned | Alimera Sciences Inc, Atlanta, Georgia; Psivida Inc, Watertown, Massachusetts |
| Pearson et al43 | Yes | Unclear | Third party masked design (patient and investigator not masked) | No losses to follow-up | Yes | Demographic characteristics were similar between implant and SOC groups; power calculation done, study adequately powered | Bausch & Lomb Inc, Rochester, New York |
| Triamcinolone | |||||||
| DRCR Network 2008 22 61 63 64 | Yes | Unclear | Partial (patients to triamcinolone dose, outcome assessors not formally masked but generally not aware of participant’s study group) | Yes (81–86% completion) | Yes | Comparison groups similar at baseline; power analysis carried out (power adequate for VA changes) | Cooperative agreement from the National Eye Institute, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and Human Services |
| Gillies et alSutter et al32 136–138 | Yes | Yes | Yes (patients, outcome assessors) | Yes (91% completion intervention, 83% control) | Yes | Comparison groups similar at baseline (but limited demographic data); power analysis carried out (power adequate for VA changes) | Sydney Eye Hospital Foundation and Juvenile Diabetes Research Foundation, New York |
| Gillies et al33 | Yes | Yes | Yes (patients, outcome assessors) | Yes (84.5% completion) | Yes | Power analysis carried out (power adequate for VA changes) | National Health and Medical Research Council, Canberra, Australia, and the Sydney Eye Hospital Foundation Sydney, Australia |
| Lam et al34 | Yes | Yes | Partial (outcome assessors) | No losses to follow-up | Yes | Comparison groups similar at baseline; power analysis carried out (power adequate for CMT changes) | Action for Vision Foundation, Hong Kong |
| Ockrim et al/Sivaprasad et al42 62 | Yes | Unclear | Unclear | Yes (94% completion) | Yes | Comparison groups similar at baseline; power analysis carried out (power adequate for VA changes) | Special Trustees of Moorfields Eye Hospital |
| Active comparator trials | |||||||
| Ahmadieh et al31 | Yes | Yes | Yes (patients and outcome assessors) | Unclear | Yes | CMT lower in control group at baseline (p<0.05), other baseline values similar; power analysis carried out (power adequate for CMT changes) | Not reported |
| DRCR Network 21 46 | Yes | Unclear | Yes (patients, except deferred laser group; outcome assessors); masking discontinued after the first year | Yes (1 year completion for 91–95% of eyes) | Yes | Comparison groups similar at baseline; power analysis carried out (power adequate for VA changes) | Cooperative agreement from the National Eye Institute, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health and Human Services; Ranibizumab provided by Genentech, triamcinolone provided by Allergan Inc; companies also provided funds to defray the study's clinical site costs |
| Lim et al55 | Yes | Unclear | Yes (investigators only) | Yes (7.5% drop out after enrolment) | Yes | Groups similar at baseline. The bevacizumab group received more injections | Not reported |
| Soheilian et al37 41 | Yes | Yes | Yes (patients and outcome assessors) | Unclear (36 week completion for 76–88%) | Yes | CMT significantly lower and VA significantly better in MPC group at baseline, other baseline values similar; power analysis carried out (power adequate for VA changes) | Ophthalmic Research Centre, Labbafinejad Medical Center, Tehran |
MPC, macular photocoagulation.