Phase I/II randomized study of proton beam with anti-VEGF for exudative age-related macular degeneration: long-term results

Autor: Lekha Mukkamala, Ala Moshiri, Inder K. Daftari, Kavita Mishra, Susanna S Park
Rok vydání: 2020
Předmět:
Vascular Endothelial Growth Factor A
medicine.medical_specialty
Visual acuity
genetic structures
Bevacizumab
Radiation retinopathy
Clinical Trials and Supportive Activities
Clinical Sciences
Immunology
Angiogenesis Inhibitors
Neurodegenerative
Eye
Ophthalmology & Optometry
Article
law.invention
Macular Degeneration
Randomized controlled trial
law
Clinical Research
Opthalmology and Optometry
Ophthalmology
Geographic Atrophy
Ranibizumab
medicine
Humans
Prospective Studies
Tomography
Eye Disease and Disorders of Vision
Anti vegf
business.industry
Evaluation of treatments and therapeutic interventions
Long term results
Macular degeneration
medicine.disease
Exudative age-related macular degeneration
eye diseases
Treatment Outcome
Optical Coherence
6.1 Pharmaceuticals
Intravitreal Injections
medicine.symptom
Protons
business
Tomography
Optical Coherence
medicine.drug
Follow-Up Studies
Zdroj: Eye (London, England), vol 34, iss 12
Eye (Lond)
Popis: BACKGROUND/OBJECTIVE: To determine if treatment of exudative age-related macular degeneration (eAMD) using proton beam therapy (PBT) combined with intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy is safe and effective long term. SUBJECT/METHODS: Thirty eyes with newly diagnosed eAMD were enrolled in a phase I/II prospective, sham-controlled double-masked university study. Eyes were randomized 1:1:1–24 GyE, 16 GyE or sham radiation, and treated with three initial monthly intravitreal ranibizumab or bevacizumab. Subsequent anti-VEGF reinjection was based on monthly optical coherence tomography and examination for 2 years and standard of care thereafter. RESULTS: A total of 23 eyes completed 2-year study follow-up, of which 16 maintained monthly follow-up. Mean best-correct visual acuity (BCVA) at 2 years was similar among treatment groups (p > 0.05). The 24 GyE group required fewer anti-VEGF injections when compared with the sham group at 2 years (4.67 ± 1.9 vs 9.67 ± 3.5; p = 0.017). Extended follow-up (mean 4 years) available in 22 eyes showed persistent reduced need for anti-VEGF therapy among eyes treated with 24 GyE compared with sham radiation (2.0 ± 1.6 vs 4.84 ± 2.4 per year, p = 0.008). New and increasing geographic atrophy (GA), noted in some eyes in all treatment groups, resulted in decreased mean BCVA from baseline for the 24 GyE group on extended follow-up (p = 0.009). Possible mild radiation retinopathy noted in 15% of eyes was not visually significant. CONCLUSIONS: Initial treatment combining PBT (24 GyE) with intravitreal anti-VEGF therapy appears to decrease the need for anti-VEGF reinjection in eyes with newly diagnosed eAMD. Radiation retinopathy risk was low and does not appear visually significant. Long-term vision was limited by GA development especially in the 24 GyE group.
Databáze: OpenAIRE
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