July 2018
Volume 59, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2018
A Randomized, Double Masked, Prospective Clinical Trial To Evaluate Pain and Inflammation after Intravitreal Injection of Aflibercept or Ranibizumab in Patients with Diabetic Macular Edema: The SOLAR Study
Author Affiliations & Notes
  • Arshad M. Khanani
    Sierra Eye Associates, Reno, Nevada, United States
  • Greg L Cohen
    Sierra Eye Associates, Reno, Nevada, United States
  • Greggory M Gahn
    University of Nevada, School of Medicine, Reno, Nevada, United States
  • Lauren Hill
    Independent Statistical Consultant, Denver, Colorado, United States
  • Aamir Aziz
    University of Nevada, Reno, Nevada, United States
  • Micaela Koci
    University of Nevada, School of Medicine, Reno, Nevada, United States
  • Peter D Freeman
    Sierra Eye Associates, Reno, Nevada, United States
  • Sarah A Taylor
    University of Massachusetts, Boston, Massachusetts, United States
  • Footnotes
    Commercial Relationships   Arshad Khanani, Aerpio (F), Aerpio (C), Alcon (F), Alcon (C), Alimera (C), Allergan (F), Allergan (C), Allergan (R), Clearside (F), Digisight (F), Genentech (R), Genentech (C), Genentech (F), Neurotech (F), Novartis (F), Novartis (C), Ophthotec (F), Opthea (F), Santen (C), Thrombogenics (F), Thrombogenics (C), Thrombogenics (R); Greg Cohen, Genentech (F); Greggory Gahn, None; Lauren Hill, None; Aamir Aziz, None; Micaela Koci, None; Peter Freeman, None; Sarah Taylor, None
  • Footnotes
    Support  Genentech
Investigative Ophthalmology & Visual Science July 2018, Vol.59, 1475. doi:
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      Arshad M. Khanani, Greg L Cohen, Greggory M Gahn, Lauren Hill, Aamir Aziz, Micaela Koci, Peter D Freeman, Sarah A Taylor; A Randomized, Double Masked, Prospective Clinical Trial To Evaluate Pain and Inflammation after Intravitreal Injection of Aflibercept or Ranibizumab in Patients with Diabetic Macular Edema: The SOLAR Study. Invest. Ophthalmol. Vis. Sci. 2018;59(9):1475.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : To compare intraocular inflammation and eye pain within the first 7 days following an intravitreal (IVT) injection of either aflibercept (AFL) or ranibizumab (RBZ) in patients with diabetic macular edema (DME).

Methods : Patients with DME (treatment naïve or no IVT within 90 days), with best correct visual acuity (BCVA) of 20/400 or better, and no history of uveitis, were randomized to receive either AFL 2.0 mg or RBZ 0.3 mg. A non-injecting ophthalmologist (GC), masked to treatment allocation, evaluated patients at baseline, at visit 1 (between 24 and 48 h post injection) and at visit 2 (5-7 days post injection). Anterior chamber inflammation (ACI) was graded according to the Standardization of Uveitis Nomenclature working group classifications. Vitreous inflammation (VI) was defined as the presence of vitreous cells on a graded scale from 0 to 4. Pain was assessed using a standard script and quantified on a scale of 0 to 10.

Results : 100 patients were enrolled. 50 received RBZ and 50 received AFL. Patients in each group had similar baseline characteristics, with 61% being male, a mean age of 64.1 years, and a mean BCVA of 70.8 letters. 6 RBZ patients (12%) and 10 AFL patients (20%) had ACI at visit 1 (p=0.41). At visit 2,1 patient (2%) in the RBZ group and 3 patients (6%) in the AFL group had ACI (p=0.62). VI was minimal at both visits, with 2 RBZ patients (4%) and 3 AFL patients (6%) at visit 1 and 0 RBZ patients and 2 AFL patients (4%) at visit 2 experiencing VI. Absence of pain was similar between groups at visit 1, with 22 subjects (44%) in each group experiencing no pain. At visit 1, 9 patients (18%) in the AFL group had severe pain compared to 7 patients (14%) in the RBZ (p=0.83). At visit 2, 40 patients (80%) in the RBZ group experienced no pain compared with 45 patients (90%) in the AFL group, while 3 patients (6%) in the AFL group and 2 patients (4%) in the RBZ group had severe pain (p=0.14).

Conclusions : ACI occurred more often in patients receiving AFL compared to RBZ, though this difference was not statistically significant. Absence of pain at visit 1 was comparable between RBZ and AFL. These findings suggest that AFL treated eyes may be more likely to have post injection inflammation. Further studies with larger sample sizes will be necessary to verify this observation.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.

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