Author: Naima Zaheer (United Kingdom)
Co-authors: Hema Kolli, Dipali Aralikatti, Shalika Perera, Alia Al-Mousawi, Bushra Mushtaq, Randhir Chavan
Purpose
To evaluate the efficacy of intravitreal Aflibercept in treating diabetic macular oedema in a real-world setting.
Setting/Venue
Birmingham and Midlands Eye Centre, City Hospital, Sandwell and West Birmingham NHS trust
Methods
We retrospectively analysed the clinical notes of the patients with new onset diabetic macular oedema (DMO) and commenced on intravitreal Aflibercept according to the NICE guidelines, between January 2015 and December 2017. Aflibercept 2mg was administered at each treatment visit, using the standard intravitreal injection technique under sterile conditions. We studied 3-year follow-up results of these patients. Patients with follow-up of less than a year after the Aflibercept treatment were not included. Patient demographics were documented, and baseline data collected for visual acuity (VA), stage of diabetic retinopathy, central macular thickness (CMT), lens status and intraocular pressure (IOP). Previous treatment of macular oedema with laser or intravitreal bevacizumab was noted. After the loading dose, VA and CMT readings were recorded at months 3, 6, 12, 24 and 36. Any complications during the follow-up period were documented. Data was analysed using Statistical program for social sciences (SPSS). The VA (ETDRS letters) and CMT readings before and 3-year after injections were analysed using paired t-test. Mean reduction in CMT and gain in VA were calculated and p value less than 0.05 was considered significant. Significant improvement or deterioration in VA was defined as gain or loss in VA ≥15 letters.
Results
During study duration, new onset DMO was treated with aflibercept in 28 eyes of 23 patients. Follow-up of 1, 2, and 3-years was completed by 28, 26 and 25 eyes, respectively. Mean age of 23 patients was 63.1±7.2 years. 56.5% were male and 43.5% were female patients. 91.3% had type 2 diabetes. Bilateral treatment was required in 21.7%. The mean number of injections in the year- 1, 2, and 3 were 4.2, 1.3 and 1.6, respectively without any rescue treatment. In 57.1% eyes, no injections were required in year- 2 and 3. At the end of year 3, the mean gain in VA was 8.3±13.1 letters. The percentage of eyes with stable and improved vision were 20% and 60% respectively. The percentage of eyes with ≥15 letters visual improvement was 32.0%. The percentage of eyes with ≥15 letter visual deterioration was 3.6%. At baseline, 28.6% of patients had a VA ≥70 letters, which increased to 61.5% at the end of the three-year follow up. The mean CMT before and after 3-years of treatment was 464.2±66.7 and 278.6±48.1 µm, respectively. The mean reduction in CMT was 185.6±84.0µm and p-value was less than 0.001. No injection related complications occurred in these cases.
Conlusions
In a real world setting after 3 years of treatment with Aflibercept, visual acuity was improved or stabilized in 80% cases. Almost two third of the cases had visual acuity equal to or more than 70 letters at the end of 3 years of treatment. Less than 5% had ≥15 letters deterioration in vision. Aflibercept is effective and well tolerated with low risk of complications.
Financial Disclosure
Hema Kolli: Travel Grant from Bayer & Novartis Bushra Mushtaq: Advisory board member and speaker for Alimera Science, Allergan, Bayer, Novartis and ORAYA therapeutics. Also reports travel grants and/or personal fees from Novartis, Bayer, and Alimera, outside the submitted work. Randhir Chavan: Advisory board member for Bayer and speaker for Novartis. Also reports personal fees from Bayer as an advisory board member, and personal fees from Novartis as a speaker, outside the submitted work. All other Authors have no financial disclosures
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