Abstract
Purpose :
To evaluate the 24-week visual and anatomical effects of prn intravitreal bevacizumab (prn-IVB; 1.25mg/0.05 cc) or quarterly intravitreal triamcinolone (qIVT; 1.00mg/0,03 cc) in patients who have persistent edema after 24-weeks of “pro re nata”(prn) IVB therapy.
Methods :
The current study is a prospective randomized clinical trial registered at ClinicalTrials.gov (NCT02985619). Seventy-four patients (100 eyes) with center-involving diabetic macular edema (DME) were enrolled and underwent comprehensive ophthalmologic evaluation at baseline and every 4 weeks up to week 48, and included assessment of best-corrected visual acuity (BCVA), lens status evaluation according to lens opacity classification system III (LOCS III), fluorescein angiography and spectral domain optical coherence tomography (Spectralis, Heidelberg, Germany). Patients received prn 1.25 mg (0.05 cc) IVB throughout 24 weeks if central subfield thickness (CSFT) was greater than 300 µm. At week 24, patients who had recurrent or persistent edema (CSFT>300) were randomized 1:1 to Group 1 (prn IVB therapy) or Group 2 (quarterly IVT therapy). Patients with no recurrent or persistent edema (CSFT ≤ 300 µm) at week 24 were comprised to Group 3 and continued receiving prn IVB therapy. Retreatment criteria was performed if CSFT > 300 µm for all groups.
Results :
To date, 83 eyes completed the 24-week follow-up visit. Mean age ± SD was 69.9 ± 7.45. Mean HbA1C level ± SD was 10.8 ± 1.60. At baseline, mean BCVA ± SEM (logMAR) was 0.56 ± 0.0528 and did not change significantly at week 24: 0.54 ± 0.0603 (p>0.05). At baseline, mean CSFT (µm) ± SEM was 441.3 ± 25.9 and significantly reduced to 398.4 ± 20.4 at week-24 (p<0.05). At week 24, 79.5% of patients had CSFT>300 µm and were randomized to persistent prn-IVB group (Group I) or quarterly IVT group (Group II). Also 20.5% of patients had CSFT ≤ 300 µm and continued as responsive prn-IVB group (Group III). There were no significant changes on lens status and intraocular pressure after the first 24 weeks of follow-up (P<0.05).
Conclusions :
At week 24, 79,5% of patients treated with prn bevacizumab has persistent DME (CSFT>300um) after 24-week of follow-up. Further analysis after week 48 will provide data of prn bevacizumab versus quarterly IVT for persistent DME treatment.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.