Maturi 2015.

Methods	Study design: parallel group RCT Unit of randomisation: participants were randomly allocated to treatment. For participants in whom both eyes were eligible, the right eye was randomised to combination therapy and the left eye was assigned to monotherapy. Number randomised: Total: 40 eyes, 30 participants. 10 people had both eyes enrolled Intervention arms: 21 combination therapy (anti‐VEGF/steroid), 19 monotherapy (anti‐VEGF) Unit of analysis: individual eyes Number analysed: Total: 35 eyes 1 year follow‐up on 18/21 eyes in anti‐VEGF/steroid group (2 withdrew, 1 lost to follow‐up) and 17/19 of anti‐VEGF group (1 withdrew, 1 lost to follow‐up).
Participants	Country: USA Mean age: 61 years Sex: 13 women; 17 men Underlying conditions: DMO Inclusion criteria: aged 18 years or older, BCVA scores between 24 and 78, early treatment of Diabetic Retinopathy Study letters (20/32–20/320 Snellen equivalent), and the presence of DMO (because of type 1 or 2 diabetes mellitus) with a CMT of greater than 250 μm measured by time‐domain OCT Exclusion criteria: intravitreal anti‐VEGF injection within the previous 4 weeks, IVS injection within the previous 8 weeks, and macular laser within the previous 16 weeks, iris neovascularisation, poorly controlled diabetes mellitus (HbA1c > 10 mg/dL), a known history of intraocular pressure increase because of corticosteroids that would not be adequately controlled with 2 topical glaucoma medications, and any condition that in the opinion of the investigator might compromise the results of the trial or preclude the participant from completing all study visits. Female participants needed a negative pregnancy test and the use of a contraceptive.
Interventions	Intervention: intravitreal bevacizumab (1.25mg) and dexamethasone implant (0.7mg) Comparator: intravitreal bevacizumab (1.25mg) Bevacizumab was given at baseline and 1 month, dexamethasone implant was given at 1 month. Bevacizumab injections were repeated at months 2, 3, 4, 6, 7, 8, 10, and 11 when the CMT > 250 μm, and the ETDRS VA score was < 80 letters (20/25); dexamethasone implants were re‐injected at months 5 and 9 according to the same criteria.
Outcomes	Visual acuity (ETDRS letters) at 12 months Central subfield thickness (OCT) at 12 months Speed of visual improvement: time until gain 15 letters Number of injections required Length of follow‐up: 1 year
Notes	Trial registration: not stated Source of funding: supported by an investigator‐initiated trial grant from Allergan, Inc. The Leona M and Harry B Helmsley Charitable Trust provided funding for the statistical centre at the Jaeb Center for Health Research to conduct the statistical analyses. Declaration of interest: Quote "R. K. Maturi, Allergan, Regeneron: Advisory Board; Ely Lilly, Jaeb Center for Health Research: consultant; Alcon, Alimera, Quark: subinvestigator; Allergan, Sanofi, Eyegate, Glaxosmithkline, Jaeb Center, Parexel, Santen: principal investigator and M. W. Stewart, Allergan, Regeneron: Advisory Board, Boehringer‐Ingelheim: consultant. The remaining authors have no conflicting interests to disclose." Date study conducted: May 2011 to January 2012
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Generation of the allocation sequence not reported.
Allocation concealment (selection bias)	Unclear risk	Allocation concealment not reported.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Participants were masked to the treatment modality; investigators performing interventions were not.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not specified in publication.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	The 12‐month evaluation was performed on 18 of 21 eyes in the combination group (2 withdrew and 1 was lost to follow‐up) and 17 of 19 eyes in the bevacizumab monotherapy group (1 withdrew and 1 was lost to follow‐up). The exact reasons for participants exiting the study early were not published.
Selective reporting (reporting bias)	Low risk	VA, central subfield thickness, injection load and safety outcomes were reported.
Other bias	Unclear risk	Both eyes being eligible to allocation in a single individual poses the theoretical potential to influence outcomes in the fellow eye via systemic absorption.