Citations: Boyer DS, Faber D, Gupta S, Patel SS, Tabandeh H, Li XY, Liu CC, Lou J, Whitcup SM; Ozurdex CHAMPLAIN Study Group. Dexamethasone intravitreal implant for treatment of diabetic macular edema in vitrectomized patients. Retina. 2011 May;31(5):915-23.
- Intravitreal aflibercept is safe and effective for treatment of macular edema secondary to central retinal vein occlusion (CRVO)
- Monthly aflibercept for 6 months resulted in improvement of macular edema, vision, and patient-reported visual function, as well as reduced neovascular complications compared to sham injections
- Once transitioned to a PRN regimen with monthly monitoring (after 6 months of monthly treatment), eyes that received monthly aflibercept maintained these improvements at 1 year with a decreased injection burden. Eyes that received monthly sham injections had improvement in visual and anatomic outcomes after switching to PRN aflibercept.
- Once transitioned to a PRN regimen with less frequent monitoring after 1 year (at least quarterly examinations), visual and anatomic gains during the first year of the study declined, indicating that less frequent monitoring may be insufficient to control the disease.
To evaluate safety and effectiveness of dexamethasone intravitreal implant (DEX implant, 0.7mg) in previously vitrectomized eyes of diabetic patients with diabetic macular edema (DME).
Phase 2, open-label, multicenter study
Major inclusion criteria:
- Diabetic macular edema and a history of pars plana vitrectomy (PPV)
- The study eye was required to have central retinal thickness over 275μm and best corrected visual acuity (BCVA) between 20/40 and 20/320.
- Patients received a DEX implant in the study at the baseline visit
- Patients were evaluated on Day 2, Weeks 1, 4, 8, 13, 20, and 26.
- Other treatments for macular edema in the study eye were prohibited during the study and could be given only if there was a concern for patient safety. No pre-defined treatment criteria.
- Primary outcome was change in central retinal thickness from baseline to Week 26
- 56 patients
- Mean duration of DME was 43 months and mean BCVA was 55 letters (~20/100) at enrollment
- No treatments other than DEX implants were administered to any study eyes during the study period.
- Patients had a mean decrease in central retinal thickness that reached peak effect at Week 8 with a mean decrease of -155.8μm
- At week 26 (primary endpoint), the mean decrease in central retinal thickness was -38.9μm
Visual acuity end-points
- Mean visual acuity
- Statistically significant improvement in BCVA was seen as early as 1 week after treatment with DEX implant.
- The largest mean increase in BCVA from baseline was 6.0 letters at Week 8, while at Week 26, the mean increase from baseline was 3.0 letters.
- Loss of < 15 letters
- At Week 26, 7% of patients lost 15 letters
- Gain of > 15 letters
- At Week 26, 11% of patients gained 15 letters
- Increased IOP was reported in 16% of study eyes. An IOP greater than 25 mmHg peaked at 9% of study eyes at Week 8 and decreased to 0% at Week 26.
- Intravitreal DEX implant reduced DME in previously vitrectomized eyes, reaching peak effectiveness between 8 – 13 weeks after injection by both anatomic and functional outcomes.