Article Date: 1/1/2008

Triple Therapy for Wet AMD Shows Impressive Results
PRESENTATIONS FROM THE RETINA SOCIETY

Triple Therapy for Wet AMD Shows Impressive Results

Dynamic disease requires complex approach.

Exudative (or "wet") age-related macular degeneration (AMD) is a "dynamic, multifactorial process involving vascular, nonvascular, and inflammatory components," conclude 2 Boston-based ophthalmologists, in a poster presented at the Retinal Society meeting in Boston. This statement by Mark S. Hughes, MD, FACS, and Delia N. Sang, MD, FACS — who practice at Ophthalmic Consultants of Boston and are affiliated with the Schepens Eye Research Institute of the Harvard Medical School — is the rationale for their methodology of administration of anti-VEGF, PDT with verteporfin, and steroid, a drug for each process in the pathology of wet AMD.

STUDY DETAILS

Drs. Hughes and Sang administered "triple" therapy to 40 treatment naive eyes, with all patients followed for 9 months. Each eye was treated with reduced-duration photodynamic therapy with verteporfin (PDT at standard fluence for 42 seconds), intravitreal dexamethasone 0.8 mg within 1-2 days following PDT, and intravitreal ranibizumab (Lucentis, Genentech) within 3-5 days of PDT. Patient eyes were monitored using monthly optical coherence tomography (OCT) and fluorescein angiography (FA) at 3, 6, and 9 months following triple therapy. If central retinal thickness (CRT) increased by >75 μm, if visual acuity (VA) decreased, or if there was evidence of fluid on OCT, ranibizumab was then administered up to every 4 weeks. Finally, if leakage was detected with FA after 3 months, then triple therapy was repeated. All subjects completed the study, with 8 subjects receiving a second session of triple therapy and 12 subjects receiving a single booster of ranibizumab within 1 to 2 months after triple therapy. No patient received more than 2 cycles of triple therapy plus one ranibizumab booster during the 9 month follow-up. The most prevalent side effects were transient lid irritation and ocular discomfort. There were no cases of endophthalmitis, no increase in intraocular pressure to >25 mm Hg, and no increased in cataract. One subject did develop a retinal pigment epithelial tear.

Mark S. Hughes, MD, FACS, and Delia N. Sang, MD, FACS, both practice with Ophthalmic Consultants of Boston and are affiliated with the Schepens Eye Research Institute of the Harvard Medical School. Both authors have received bureau and research funds from OSI/Eyetech, QLT, and Novartis.

IMPRESSIVE RESULTS

The study produced impressive results. There was a mean VA gain of 2.2 lines at the 9-month follow-up, and the largest change in mean VA occurred within the first two months, from 20/200 to 20/80. CRT decreased by an average of 183 μm by month 9, and again, the largest change took place early in that 9-month period. Drs. Hughes and Sang also presented data on the distribution of VA changes among the 40 subjects, and they broke out their VA improvements and number of treatments by lesion subtype. Finally, they presented FA and OCT images from 3 clinical cases. Drs. Hughes and Sang note that there are ongoing national clinical trials employing triple therapy in the treatment of AMD. While TAPER has been terminated, DENALI, MONT BLANC, and RADICAL are still active studies. RP



Retinal Physician, Issue: January 2008