I.
Anti-Vegf Treatments
A. How do they work
1. Inhibit vascular proliferation while preventing damage to photoreceptors
2. Used for ARMD to prevent CNVM
3. Role in DME?
B. RhuFab: studies
1. 64 pts with wet ARMD some previously treated with PDT
2. 50/53 (94%) had stable or improved vision
3. 14/53 (26%) improved 15 letters or more
4. 9.0 letters gained with treatment vs 4.9 letters lost without
C. Eye 001 studies
1. Review of most current studies
II. Triamcinolone Acetonide
A. Triamcinolone previously used as Kenalog for treatment of CME
1. Now being investigated for treatment of DME unresponsive to laser
a) steroids inhibit production of prostaglandin, known mediator of vascular
permeability
b) 16 eyes with known DME with avg 2.7 sessions of laser and 36 mos duration
2. 4 mg injected intravenously
a) mean reduction in retinal thickness by OCT of 38%
b) avg VA gain 1.3 line at 6 mos
c) complications not prohibitive
d) may be promising alternative for pts unresponsive to laser
3. Steroids also display anti-angiogenic properties as well, so being investigated for
role in wet ARMD/CNVM formation
a) 4 mg injected intrvitreal in 16 pts with VA from 20/40 to 20/400
b) VA improved 0.04 logmar in treated eyes vs 0.39 decline untreated eyes
c) May be promising treatment
III.PKC-B Inhibitor: Ruboxistaurin mesylate (formerly LY 333531)
A. First oral medication by Lilly for the treatment of diabetic microvascular
complications, specifically diabetic retinopathy
B. Protein Kinase C is believed to be involved I early hyperglycemia induced microvascular
damage
C. Also associated with VEGF driven neovascularization and vascular leakage,
characteristic of DR and DME
D. Overview of Phase 1 studies
1. Drug appears bioavailable with low incidence of adverse events
2. Well tolerated at doses up to 32 mg/d
D. Overview of Phase 2 studies
1. No significant efectiveness for preventing progression of diabetic retinal
complications
2. Larger studies needed
IV. Rheophoresis
A. Blood filtration system used in clinical trials to treat intermediate to late stage
Dry ARMD
B. How does it work?
1. eliminates known risk factors of ARMD by decreasing plasma viscosity
2. May also have impact on choroidal perfusion
C. MIRA-1 Trials: Summary
1. Appears safe and well tolerated
2. Provides a statistically and clinically relevant improvement in BCVA
3. Benefit remained stable throughout the year
4. Continuation of study is indicated with more patients
V. Anecorvate Acetate
A. Currently being studied for treatment of ARMD, either alone or with PDT
1. Single therapy
a) 25% less loss of VA with injection vs placebo
b) 18% had VA improve by at least 2 lines
c) less percent change in lesion growth
2. As an adjunct to PDT: 67% 0f pts with combined therapy had no VA loss vs 67%
treated with PDT alone
B. No clinically relevant safety issues occurred in early studies
C. May be promising as stand-alone therapy or as adjunct to PDT