Clinical Studies:
CHAMPLAIN
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.
Key Points
- 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.
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Objective:
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).
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STUDY DESIGN:
Phase 2, open-label, multicenter study
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DURATION:
26 weeks
STUDY SUBJECTS
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.
STUDY INTERVENTIONS
- 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
RESULTS
Study population
- 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.
Anatomic outcomes
- 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
Adverse Events
- 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.
CONCLUSIONS
- Intravitreal DEX implant reduced DME in previously vitrectomized eyes, reaching peak effectiveness between 8 – 13 weeks after injection by both anatomic and functional outcomes.