Marashi 2017.
Study characteristics | ||
Methods | Study design: randomised, parallel, open‐label clinical trial Unit of randomisation: participants Unit of analyses: 30 eyes of 30 participants Follow‐up: 12 months |
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Participants | Country: Syria Setting: Marashi eye clinic, AlBashir Hospital, Yamman Shuman Retina specialist at advanced ocular centre Alkalmat Hospital Number of participants: 30 (15 per group) Exclusions post‐randomisation: not reported Losses to follow‐up: not reported Age (mean (range)): bevacizumab group 52 (46 to 59) years and control group 53 (48 to 61) years Gender: 7 men and 23 women Inclusion criteria: age >= 18 years, presence of PDR which the investigator intends to manage with PRP alone but for which PRP can be deferred for at least 4 weeks in the setting of intravitreal bevacizumab; best corrected Snellen equivalent 20/320 or higher on the day of randomisation; media clarity, pupillary dilation, and study participant co‐operation sufficient to administer PRP and obtain adequate fundus photographs and OCT. Exclusion criteria: chronic renal failure requiring dialysis or kidney transplant; ischaemic systemic events; pregnant or lactating women; tractional retinal detachment involving the macula; macular oedema related to ocular surgery; ocular infection; glaucoma; aphakia; previous treatment with anti‐VEGFs or corticosteroids. |
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Interventions | Treatment: bevacizumab (1.25 mg three injections every 4 weeks and PDR was reassessed at week 18 to 20) with deferred panretinal photocoagulation (PRP) if it was necessary (and it was stopped whenever a stable PDR was achieved for the last 2 injections) Control: prompt PRP Duration: 12 months Co‐intervention: both groups could have received intravitreal bevacizumab or focal/grid laser for diabetic macular oedema; 12 participants had DME in the experimental group and 3 in the control group. |
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Outcomes | Primary: proportion of visual acuity improvement using Snellen chart or equivalent from baseline and 12 months Secondary outcomes: treatment cost at 1 year; per cent of eyes with vitreous haemorrhage at 1 year; the proportion of eyes with complete regression of neovascularisation on fundus photograph at 1 year; the proportion of eyes with progression to central sub‐field involved diabetic macular oedema at 1 year; the proportion of eyes need for vitrectomy at 12 months |
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Notes | Funding: not reported Trial registration: NCT02705274 Date conducted: between February and April 2016 Conflict of interest: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Randomized multicenter and open label double arm interventional study" |
Allocation concealment (selection bias) | Unclear risk | Quote: "Randomized multicenter and open label double arm interventional study" |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: open‐label study |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: open‐label study |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: the publication reports data for all participants. The authors did not refer to losses. |
Selective reporting (reporting bias) | High risk | Quote: "PDR complications such as vitreous haemorrhage and tractional retinal detachment along with the need of vitrectomy were not included in this study due to the small number of recruitment and short term follow‐up" Comment: The cost included in the protocol was not reported. For some continuous data (e.g. visual acuity) there were no standard deviations reported. |