Abstract | PURPOSE: To evaluate 52-week efficacy and safety of a treat-and-extend regimen of intravitreal aflibercept 2 mg on treatment-naive Type 3 neovascularization lesions. METHODS: Phase IV, prospective, open-label, single-arm, multicenter trial including patients with untreated Stage I/II Type 3 neovascularization lesions and baseline best-corrected visual acuity between 78 and 23 Early Treatment Diabetic Retinopathy Study letters. Primary endpoint: mean change in best-corrected visual acuity from baseline at 52 weeks. RESULTS: Thirty-two eyes from 32 patients were included (mean ± SD age: 78.2 ± 7.7 years, 68.8% females, baseline best-corrected visual acuity: 57.9 ± 15.4 [Snellen fraction 20/70]). Best-corrected visual acuity increased by 10.5 ± 15.9 Early Treatment Diabetic Retinopathy Study letters at Week 52 (P = 0.0001). The mean foveal and choroidal thickness decreased by 129.1 ± 80.1 µm (P < 0.0001) and 64.3 ± 96.5 (P = 0.0001), respectively. The proportion of patients with intraretinal/subretinal fluid decreased from 28 (87.5%) at baseline to 3 (11.5%) at Week 52 (P < 0.0001). Pigment epithelial detachment and lesion area showed nonsignificant changes over 52 weeks. The mean number of injections was 8.0 ± 2.0. Seven (21.9%) patients experienced treatment-related adverse events and two (6.3%) experienced serious adverse events; one (3.1%) ocular serious adverse event requiring treatment withdrawal, endophthalmitis, and one (3.1%) nonocular spontaneously resolved serious adverse event, palpitations. One (3.1%) patient experienced an APTC ATE: nonfatal stroke not related to trial treatment. CONCLUSION: A treat-and-extend regimen of aflibercept improves visual acuity and retinal edema in eyes with Type 3 neovascularization over 52 weeks with good tolerability.
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Authors | Luis Arias, Enrique Cervera, Jaume Crespí Vilimelis, José Juan Escobar, Antonio Gómez Escobar, Miguel Ángel Zapata, AFLIRAP Trial Investigators |
Journal | Retina (Philadelphia, Pa.)
(Retina)
Vol. 40
Issue 7
Pg. 1234-1244
(Jul 2020)
ISSN: 1539-2864 [Electronic] United States |
PMID | 31259813
(Publication Type: Clinical Trial, Journal Article, Multicenter Study)
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Chemical References |
- Angiogenesis Inhibitors
- Recombinant Fusion Proteins
- Vascular Endothelial Growth Factor A
- aflibercept
- Receptors, Vascular Endothelial Growth Factor
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Topics |
- Aged
- Angiogenesis Inhibitors
(administration & dosage)
- Drug Administration Schedule
- Female
- Follow-Up Studies
- Humans
- Intravitreal Injections
- Male
- Prospective Studies
- Receptors, Vascular Endothelial Growth Factor
(administration & dosage)
- Recombinant Fusion Proteins
(administration & dosage)
- Treatment Outcome
- Vascular Endothelial Growth Factor A
(antagonists & inhibitors)
- Visual Acuity
- Wet Macular Degeneration
(diagnosis, drug therapy)
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