Table 2. Summary of data from clinical trials of intravitreal implants.

Indications, type of study, duration of follow-up	Inclusion criteria	Endpoints	Results
Fluocinolone acetonide implant, 0.59 mg
Non-infectious posterior uveitis (13) Prospective, randomized multicenter trial 3 years	Recurrent non-infectious posterior uveitis, Status post corticosteroid treatment	Comparison of the 0.59-mg (n=110) and 2.1-mg (n=168) FA implants and untreated opposite eyes with respect to safety and effectiveness	Visual acuity improvement ≥3 lines after 3 years: 0.59-mg group: 23% (22/94) [untreated opposite eyes: 6% (5/90)] (p <0.01) undesired effects: rise in intraocular pressure by ≥10mmhg 0.59-mg group: 67% (74/110) [untreated opposite eyes: 23% (25/109)]
Diabetic macular edema (15)Prospective, randomized multicenter trial 3 years	Persistent or recurrent diabetic macular edema Visual acuity 0.05–0.4	Comparison of the 0.59-mg FA implant (n=127) with standard treatment (n=69) (focal/grid laser photocoagulation or observation) (randomized 2:1) with respect to safety and effectiveness	Visual acuity improvement ≥15 letters at 6, 12, 24, and 36 months FA implant: 16.8%, 16.4%, 31.8%, 31.1% Control group: 1.4% (p=0.0012), 8.1% (p=0.1191), 9.3% (p=0.0016), 20.0% (p=0.1566) Rise in intraocular pressure to ≥30 mmHg FA implant: 61.4% (78/127) Control group: 5.8% (4/69)
Fluocinolone acetonide implant, 0.19 mg
Diabetic macular edema (17) Prospective, randomized, placebo-controlled double-blind phase III trial 2 years	Persistent diabetic macular edema despite laser therapy	Comparison of the 0.2-µg/d (n=375) and 0.5-µg/d (n=393) FA implants and sham treatment (n=185), with possible laser therapy and/or retreatment after 12 months (randomized 2:2:1) with respect to safety and effectiveness	Visual acuity improvement ≥15 letters at 24 months FA implant 0.2 µg/d: 28.7% Control group: 16.2% (p=0.002) Rate of filtrating glaucoma surgery FA implant 0.2 µg/d: 3.7% Control group: 0.5%
Dexamethasone implant, 700 µg
Persistent macular edema (e13) Prospective, randomized multicenter phase II trial 6 months	Persistent macular edema despite treatmentVisual acuity 0.1–0.5	Comparison of the 350-µg (n=105) and 700-µg (n=105) dexamethasone implants and observation (n=105) (randomized 1:1:1) with respect to safety and effectiveness	Visual acuity improvement ≥15 letters at 3 months DEX implant 700 µg: 18% (19/105) Control group: 6% (6/105) (p=0.006) Rise in intraocular pressure by ≥ 10mmHg at some point within 6 months (not necessarily requiring surgical treatment) DEX implant 700 µg: 17% (17/101) Control group: 3% (3/100)
Macular edema after CRVO and BRVO (23. 24) Prospective, randomized multicenter phase III trial 6 months, randomized and blinded 6 further months, open trial with retreatment when indicated (700 µg implant)	Macular edema after BRVO (duration 6 weeks – 12 months), after CRVO (duration 6 weeks – 9 months) Visual acuity 0.1–0.4	Comparison of the 350-µg (n=412) and 700-µg (n=421) dexamethasone implants and observation (n=423) (randomized 1:1:1) with respect to safety and effectiveness	Time to visual acuity improvement ≥15 letters Significantly shorter in the treatment groups than in the control group (p<0.001) percentage of patients with visual acuity improvement ≥15 letters (days 30 – 90 after implantion) significantly higher in the treatment groups than in the control group (p <0.001) rise in intraocular pressure by ≥10mmhg 60 days after implantion dex implant 700 µg: 12.6% (after 1 st implantion)
Non-infectious intermediate or posterior uveitis (25) Prospective, randomized multicenter phase III trial 6 months	Non-infectious intermediate or posterior uveitis Visual acuity 0.03–0.63	Comparison of the 350-µg (n=76) and 700-µg (n=77) dexamethasone implants and observation (n=76) (randomized 1:1:1) with respect to safety and effectiveness	Regression of vitreous haze (Vitreous Haze Score 0) at 8 weeksDEX implant 700 µg: 47% (36/77) Control group: 12% (9/76) (p <0.001) percentage of patients with visual acuity improvement ≥15 letters significantly higher in the treatment groups than in the control group [p <0.001 (700-µg group), p ≤0.027 (350-µg group)] rise in intraocular pressure to ≥25 mmhg after implantion dex implant 700 µg: 7.1% control group: 4.2% (p >0.05)

BRVO, branch retinal vein occlusion; CRVO, central retinal vein occlusion; FA, fluocinolone acetonide; DEX, Dexamethasone