June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Endolaserless Vitrectomy with Intravitreal Aflibercept Injection (IAI) for Proliferative Diabetic Retinopathy (PDR)-Related Vitreous Hemorrhage (LASER LESS TRIAL)
Author Affiliations & Notes
  • Dennis M Marcus
    Ophthalmology, Southeast Retina Center, Augusta, Georgia, United States
  • Harinderjit Singh
    Ophthalmology, Southeast Retina Center, Augusta, Georgia, United States
  • Amina Farooq
    Ophthalmology, Southeast Retina Center, Augusta, Georgia, United States
  • Davis Starnes
    Ophthalmology, Southeast Retina Center, Augusta, Georgia, United States
  • Harveen Walia
    Ophthalmology, Southeast Retina Center, Augusta, Georgia, United States
  • Footnotes
    Commercial Relationships   Dennis Marcus, Acucela (F), Alcon (F), Alimera (F), Alimera (C), Allegro (F), Allergan (F), Apellis (F), Astellas (F), Genentech/Roche (F), Genentech/Roche (C), GSK (F), Neurotech (F), Ohr (F), Ophthotech (F), Pfizer (F), Regeneron (F), Regeneron (C), Thrombogenics (F), Thrombogenics (C), Tyrogenex (F); Harinderjit Singh, acucela (F), Alcon (F), Alimera (F), Allegro (F), Allergan (F), Appelis (F), Astellas (F), Genentech/Roche (F), GSK (F), Neurotech (F), Ohr (F), Ophthotech (F), Pfizer (F), Regeneron (F), Thrombogenics (F), Tyrogenex (F); Amina Farooq, None; Davis Starnes, None; Harveen Walia, None
  • Footnotes
    Support  Investigator initiated trial supported by Regeneron
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 5036. doi:
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      Dennis M Marcus, Harinderjit Singh, Amina Farooq, Davis Starnes, Harveen Walia; Endolaserless Vitrectomy with Intravitreal Aflibercept Injection (IAI) for Proliferative Diabetic Retinopathy (PDR)-Related Vitreous Hemorrhage (LASER LESS TRIAL). Invest. Ophthalmol. Vis. Sci. 2017;58(8):5036.

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

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Abstract

Purpose : For PDR eyes not requiring vitrectomy, DRCR Protocol S demonstrated better visual acuity outcomes, decreased visual field sensitivity loss, need for vitrectomy, and DME development in the ranibizumab group compared to the panretinal photocoagulation (PRP) group. IAI may represent a useful therapy with vitrectomy for PDR-related vitreous hemorrhage. IAI may treat neovascularization and unrecognized DME in the setting of vitreous hemorrhage and may be a viable alternative to intraoperative endolaser during vitrectomy. We will determine the safety, visual, and anatomic outcomes when aflibercept is used in the setting of PDR-related vitreous hemorrhage undergoing endolaserless vitrectomy.

Methods : Phase I/II open label, randomized, prospective, interventional study of endolaserless vitrectomy and 2mg IAI for PDR-related vitreous hemorrhage. Eyes receive one preoperative and intraoperative IAI. Eyes are randomized to a q8 week group receiving 4 postoperative q4week IAI followed by q8 week IAI for 52 weeks or to a q16week group receiving 2 postoperative q4week IAI followed by q16week IAI for 52 weeks. Additional IAI for PDR progression or DME may be used. The following are performed monthly: Adverse event monitoring, ETDRS BCVA, IOP measurement, slit lamp biomicroscopy, indirect ophthalmoscopy, and SD-OCT. Quarterly wide-field fluorescein angiography and fundus photography are performed. Visual field testing is performed at weeks 4 and 52.

Results : Thirteen patients (4 females; 12 Type II and 1 Type I diabetic; average age 55 (range: 27-77 years); 5 Caucasian, 7 African American, 1 Asian; 3 pseudophakic and 9 phakic) have thus far, been enrolled. Twelve eyes underwent endolaserless vitrectomy with IAI and were randomized. Preoperative BCVA was 33 letters (snellen equivalent 20/250) (range 0-84 letters). At 1 month postoperatively, average visual gain was 33 (range: -4 to +74) letters. For 6 eyes with 2 months postoperative follow-up, average visual gain was 46 (range 5-82 gain) letters. OCT CST at 1 month postoperatively was 322 um; 3 of 10 eyes demonstrated DME with OCT CST >300 um. No short term ocular or systemic adverse events were observed at 1 month postoperatively.

Conclusions : Endolaserless vitrectomy with IAI for PDR-related vitreous hemorrhage demonstrates short-term safety with significant improvement in visual acuity.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.

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