Journal of Clinical and Experimental Ophthalmology
Open Access

Abstract

Polypill Therapy for Recalcitrant Clinically Significant Macular Edema: A Prospective Case Series

Alper Bilgic, Aditya Sudhalkar, Jay Trivedi, Tejas Desai, Usha Vyas, Bakulesh Khamar

Abstract:
Background: To determine the utility of the polycap in treatment of refractory diabetic macular edema.
Methods: Prospective case series. The study included 60 patients (>18 years; 37 males) with well controlled type
2 diabetes mellitus, hypertension and dyslipidemia and diffuse CSME (clinically significant macular edema)
refractory to conventional therapy. Patients included had received at least 1). Three intravitreal ranibizumab
injections and two sessions of macular laser photocoagulation. A complete ocular and systemic exam was
performed along with FFA (fluorescein angiography) and OCT (Optical Coherence Tomography). The polypill was
administered orally once daily in the morning after breakfast. Monthly follow-ups were scheduled. Appropriate
statistical analysis was done. Outcome measures: Primary-the change in VA from baseline over one year.
Secondary-The change in CMT over one year and adverse events.
Results: The median age was 60.4 ± 5.42. Median duration of diabetes: 13.24 ± 4.18 years. 21 patients were on
both oral hypoglycemic and insulin therapy. The median duration of CSME was 11.65 ± 3.47 months (5-26 months).
Baseline VA improved from 0.72 ± 0.16 logMAR to 0.64 ± 0.09 logMAR (p=0.03) at one year. Median CMT improved
from 364.2 ± 31 microns to 297.23 ± 30.11 at one year (p=0.027). Systemic parameters too improved significantly.
No adverse events were noted.
Conclusion: The polypill appeared safe and effective in treatment of recalcitrant diabetic macular edema,
probably by improved compliance. Trial Registration: N/A.