Aflibercept for Diabetic Macular Oedema: Outcomes Using a Treat and Extend Protocol

The study will take the form of a prospective interventional case series and involve the use of 2.0mg aflibercept in treatment naïve centre-involving diabetic macula oedema (DMO). The participants will receive treatment according to a treat and extend protocol. The treat-and-extend protocol denotes the following: There will be an initial loading phase of 3 injections given 4 weeks apart, follow up and reinjection will occur at 4-week intervals until the macula is at pre-threshold for inclusion in the study (that is, the visual acuity is better than 78 letters (6/9.5) and CST has reached less than300um) or there has been no improvement in BCVA by greater than or equal to 5 letters or no further improvement in CST by 10% or more for the last two visits. Achieving these outcomes will indicate stability. Once the macula is stable, follow up and injection will be increased by 2 week intervals. If there is no loss of BCVA by greater than or equal to 5 letters and no increase in CST by 10% or more this 2 week extension with treatment will be continued out to 12 weeks. Where a patient reaches a 12 week interval, and remains stable, this will be continued for two further 12 week intervals. If stability remains at the fourth 12 week review, the injection will be withheld and the participant will be reviewed four weekly with BCVA and OCT scanning. Should stability be preserved after three four weekly checks no further injection will be given and the participant will be monitored 3 monthly as they would routinely in quiescent DMO. If there is a loss of BCVA by greater than or equal to 5 letters or an increase in CST by 10% or more the participant will be re-injected and returned for review and further treatment at four weeks and then re-extended as indicated. If, at any time, there is a deterioration of 5 or more letters in BCVA or an increase in CST of 10% or more, then the interval is reduced by 2 weeks at a time until the macula is once again stable. The patient can then be re-extended. With this regimen, the patient receives an injection at each follow up and the interval of each follow up after the initial loading phase is determined by the treat-and-extend re treatment criteria. Injections will be administered to the patients as required by the Ophthalmology study doctor for the 24 month duration of the study. After the study is completed patients will be reviewed as outpatients as per standard clinical practice. Patients are reminded at the point of signing consent of the importance of attending all study visits. Staff contact details are provided should any issues arise.