Table 2.
Main epimacular brachytherapy clinical trials: characteristics, design, main outcomes, and ocular adverse effects
| Reference | Study design | n | Dose and exposure | Isotope | Anti-VEGF therapy association | Main outcomes | Main ocular adverse events |
|---|---|---|---|---|---|---|---|
| Avila et al65 | Prospective (12 months) non-controlled and non-randomized multicenter clinical trial | 34 naïve | Dose: 24 Gy time: 5 minutes | Strontium-90 | Bevacizumab 10 days before radiation Bevacizumab just after radiation |
Loss of BCVA (<15 letters): 91.0% Unchanged or improved BCVA (>0 letters): 68.0% Gain of BCVA (>15 letters): 31.0% |
Cataract (25.0%); CNV leakage (20.5%) Subretinal fibrosis (6.0%); increased IOP (6.0%) Cystoid macular edema (3.0%) |
| Avila et al66 | Prospective (36 months) non-controlled and non-randomized multicenter clinical trial | 34 naïve | Dose: 24 Gy time: 5 minutes | Strontium-90/Yttrium-90 | Bevacizumab just after radiation Bevacizumab 30 days after radiation Bevacizumab PRN |
Losing less than 15 letters (24–36 months): 64.7%–89.5% Gaining one or more letter (24–36 months): 3.53%–52.6% Gaining 15 or more letters (24–36 months): 14.7%–21.1% 1st year (n=34): 4 additional IVT in 4 eyes 2nd year (n=34): 10 additional IVT in 7 eyes 3rd year (n=19): 4 additional IVT in 4 eyes |
Cataract (50.0%) Retinal fibrosis (6.0%) Subretinal fibrosis (3.0%) Subretinal hemorrhage (3.0%) Epiretinal membrane (3.0%) |
| MERITAGE study, Petrarca et al68 | Prospective (36 months) non-controlled and non-randomized multicenter clinical trial | 53 treated | Dose: 24 Gy time: 3–5 minutes | Strontium-90/Yttrium-90 | Ranibizumab just after radiation Ranibizumab PRN |
Losing less than 15 letters (24 months): 68.1% Gaining one or more letter (24 months): 40.4% Gaining 15 or more letters (24 months): 8.5% Retreatment injections: mean 8.3 (24 months) |
Cataract (100.0%); subconjunctival hemorrhage (71.7%); Retinal hemorrhage (56.6%); subretinal fibrosis (20.8%) RPE changes/atrophy (17.0%) Increase IOP (15.1%) |
| CABERNET study, Dugel et al69 | Prospective (36 months) controlled and randomized multicenter Phase III clinical trial | 494 naïve | Dose: 24 Gy time: 3–5 minutes | Strontium-90/Yttrium-90 | Ranibizumab loading dose (×2) just after radiation Ranibizumab loading dosis (×3) monotherapy Ranibizumab PRN |
Losing less than 15 letters (24 months): 77.0% EMBT vs 90.0% control Gaining 15 or more letters (24 months): 16.0% EMBT vs 26.0% control Ranibizumab injections (24 months): 6.2% EMBT vs 10.4% control |
Cataract: 40.0% EMBT vs 11.0% ranibizumab Disease progression: 9.0% vs 2.0% ranibizumab Retinal detachment: 2.0% for both groups Retinal hemorrhage: 1.0% for both groups Vitreous hemorrhage: 1.0% EMBT vs 2.0% ranibizumab Endophthalmitis: 1.0% EMBT vs none ranibizumab Radiation retinopathy: 3.0% EMBT vs none ranibizumab |
Abbreviations: PRN, pro re nata (as needed); BCVA, best corrected visual acuity; IVT, intravitreal therapy; EMBT, epimacular brachytherapy; CNV, choroidal neovascularization; IOP, intraocular pressure.