Switch to aflibercept in the treatment of neovascular age-related macular degeneration: 30-month results / Mudança de tratamento para o aflibercepte no tratamento da Degeneração Macular neovascular Relacionada à Idade: resultados de 30 meses

ABSTRACT Purpose: This study was conducted to evaluate visual function and changes in the central macular thickness of patients with unresponsive neovascular age-related macular degeneration who were switched from ranibizumab (Lucentis®) to aflibercept (Eylea®) treatment at 30 months. Methods: This retrospective study examined patients with neovascular age-related macular degeneration who were switched to aflibercept after ≥6 previous intravitreal ranibizumab injections at 4- to 8-week intervals. All patients were switched to intravitreal aflibercept (2.0 mg) and analyzed after 3 consecutive injections followed by a prore nata dosing regimen and after 30 months of treatment. Best corrected visual acuity, biomicroscopic examination, intraocular pressure, fundus examination, and central macular thickness were recorded at the start of treatment, before the transition to intravitreal aflibercept treatment, and at 6, 12, 18, 24, and 30 months of intravitreal aflibercept treatment. Results: A total of 33 eyes met the inclusion criteria. The median age of the patients was 73.57 ± 7.98 years, and 21 (61.8%) patients were males and 12 (35.3%) were females. Before the transition, the patients received a mean of 16.8 ± 8.8 ranibizumab injections (range 6-38).After the transition to intravitreal aflibercept treatment, the mean number of aflibercept injections was 9.09 ± 3.94. No significant differences were observed in best corrected visual acuity after the aflibercept switch in any of the months. The central macular thickness was significantly decreased at 6, 12, 18, and 30 months (p=0.01, p=0.03, p=0.05, p=0.05, p<0.001, respectively). Conclusion: Patients with neovascular age-related macular degeneration who were switched to intravitreal aflibercept treatment due to unresponsiveness to intravitreal ranibizumab exhibited a significant anatomic improvement in the retina, and although this state persisted, there was no significant functional gain.(AU)

RESUMO Objetivo: Avaliar, depois de 30 meses, a função visual e as alterações na espessura macular central de pacientes com degeneração macular relacionada à idade sem resposta terapêutica ao ranibizumabe (Lucentis®) que mudaram seu tratamento para o aflibercepte (Eylea®). Métodos: Realizou-se um estudo retrospectivo de pacientes com degeneração macular neovascular relacionada à idade que mudaram o tratamento para o aflibercepte após 6 ou mais injeções intravítreas de ranibizumabe a intervalos de 4-8 semanas. Todos os pacientes mudaram para o aflibercepte intravítreo (2,0 mg) e depois de 3 injeções consecutivas, seguidas de um regime de dosagem pro re nata, foram avaliados após 30 meses de tratamento. A melhor acuidade visual corrigida, o exame biomicroscópico, a pressão intraocular, a fundoscopia e a espessura macular central foram registrados no início do tratamento, antes da transição para o tratamento com aflibercepte intravítreo e aos 6, 12, 18, 24 e 30 meses de tratamento com o aflibercepte intravítreo. Resultados: Satisfizeram aos critérios de inclusão 33 olhos. A mediana da idade dos pacientes foi de 73,57 ± 7,98 anos. Dos pacientes, 21 (61,8%) eram homens e 12 (35,3%) eram mulheres. Antes da transição para o tratamento com o aflibercepte intravítreo, os pacientes receberam em média 16,8 ± 8,8 injeções de ranibizumabe (faixa 6-38).Depois da transição, o número médio de injeções de aflibercepte foi de 9,09 ± 3,94. Não houve diferenças significativas na melhor acuidade visual corrigida depois da mudança para o aflibercepte em qualquer das avaliações. Houve diminuição significativa da espessura macular central aos 6, 12, 18 e 30 meses (respectivamente, p=0,01, p=0,03, p=0,05, p=0,05 e p<0,001). Conclusão: Pacientes com degeneração macular neovascular relacionada à idade que mudaram seu tratamento para o aflibercepte intravítreo devido à falta de resposta ao ranibizumabe intravítreo, tiveram melhora anatômica significativa da retina; mas embora esse estado tenha persistido, não foi observado nenhum ganho funcional significativo.(AU)

Switch to aflibercept in the treatment of neovascular age-related macular degeneration: 30-month results.

PURPOSE: This study was conducted to evaluate visual function and changes in the central macular thickness of patients with unresponsive neovascular age-related macular degeneration who were switched from ranibizumab (Lucentis®) to aflibercept (Eylea®) treatment at 30 months. METHODS: This retrospective study examined patients with neovascular age-related macular degeneration who were switched to aflibercept after ≥6 previous intravitreal ranibizumab injections at 4- to 8-week intervals. All patients were switched to intravitreal aflibercept (2.0 mg) and analyzed after 3 consecutive injections followed by a prore nata dosing regimen and after 30 months of treatment. Best corrected visual acuity, biomicroscopic examination, intraocular pressure, fundus examination, and central macular thickness were recorded at the start of treatment, before the transition to intravitreal aflibercept treatment, and at 6, 12, 18, 24, and 30 months of intravitreal aflibercept treatment. RESULTS: A total of 33 eyes met the inclusion criteria. The median age of the patients was 73.57 ± 7.98 years, and 21 (61.8%) patients were males and 12 (35.3%) were females. Before the transition, the patients received a mean of 16.8 ± 8.8 ranibizumab injections (range 6-38).After the transition to intravitreal aflibercept treatment, the mean number of aflibercept injections was 9.09 ± 3.94. No significant differences were observed in best corrected visual acuity after the aflibercept switch in any of the months. The central macular thickness was significantly decreased at 6, 12, 18, and 30 months (p=0.01, p=0.03, p=0.05, p=0.05, p<0.001, respectively). CONCLUSION: Patients with neovascular age-related macular degeneration who were switched to intravitreal aflibercept treatment due to unresponsiveness to intravitreal ranibizumab exhibited a significant anatomic improvement in the retina, and although this state persisted, there was no significant functional gain.

Quality of life among patients with age-related severe macular degeneration assessed using the NEI-VFQ, HADS-A, HADS-D and SF-36 tests. A cross-sectional study.

BACKGROUND: Exudative age-related macular degeneration (e-AMD) may cause severe central vision loss. Patients with e-AMD can experience difficulties in daily basic activities and suffer from psychological problems. Our aim was to assess quality of life (QoL) and anxiety and depression status among patients with e-AMD. DESIGN AND SETTING: Cross-sectional study in a state university. METHODS: We included 200 e-AMD patients and 120 age and gender-matched controls. We assessed QoL using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) and the Short Form (SF)-36 test; and anxiety and depression status using the Hospital Anxiety Depression Scales A and D (HADS-A and HADS-D). RESULTS: The mean ages in the e-AMD and control groups were 68.40 ± 9.8 and 66.31 ± 8.98, respectively. Visual acuity among e-AMD patients was 0.37 ± 0.31 and 0.39 ± 0.32 in the right and left eyes, respectively. The e-AMD patients performed significantly worse than the controls in NEI-VFQ-25 (P < 0.05 for all items). The proportions of e-AMD patients scoring higher than the cutoffs in HADS-A and HADS-D were significantly higher than among the controls (41.5% versus 12.5% and 63.5% versus 27.5%; P < 0.001). The e-AMD patients had significantly lower mean scores than the controls for each of the SF-36 QoL items (P < 0.001). The NEI-VFQ-25 scores were significantly lower among patients with bilateral e-AMD than among those with unilateral disease (P < 0.05 for all). The HADS scores were positively correlated with duration of e-AMD and patient age, but negatively with vision levels (P < 0.05 for all items). CONCLUSION: The e-AMD patients had higher depression and anxiety scores and lower QoL scores.

Quality of life among patients with age-related severe macular degeneration assessed using the NEI-VFQ, HADS-A, HADS-D and SF-36 tests. A cross-sectional study

ABSTRACT BACKGROUND: Exudative age-related macular degeneration (e-AMD) may cause severe central vision loss. Patients with e-AMD can experience difficulties in daily basic activities and suffer from psychological problems. Our aim was to assess quality of life (QoL) and anxiety and depression status among patients with e-AMD. DESIGN AND SETTING: Cross-sectional study in a state university. METHODS: We included 200 e-AMD patients and 120 age and gender-matched controls. We assessed QoL using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) and the Short Form (SF)-36 test; and anxiety and depression status using the Hospital Anxiety Depression Scales A and D (HADS-A and HADS-D). RESULTS: The mean ages in the e-AMD and control groups were 68.40 ± 9.8 and 66.31 ± 8.98, respectively. Visual acuity among e-AMD patients was 0.37 ± 0.31 and 0.39 ± 0.32 in the right and left eyes, respectively. The e-AMD patients performed significantly worse than the controls in NEI-VFQ-25 (P < 0.05 for all items). The proportions of e-AMD patients scoring higher than the cutoffs in HADS-A and HADS-D were significantly higher than among the controls (41.5% versus 12.5% and 63.5% versus 27.5%; P < 0.001). The e-AMD patients had significantly lower mean scores than the controls for each of the SF-36 QoL items (P < 0.001). The NEI-VFQ-25 scores were significantly lower among patients with bilateral e-AMD than among those with unilateral disease (P < 0.05 for all). The HADS scores were positively correlated with duration of e-AMD and patient age, but negatively with vision levels (P < 0.05 for all items). CONCLUSION: The e-AMD patients had higher depression and anxiety scores and lower QoL scores.

Comparison of pain scores between patients undergoing panretinal photocoagulation using navigated or pattern scan laser systems.

PURPOSE: To compare the pain responses of patients with proliferative diabetic retinopathy (PDR) undergoing panretinal photocoagulation (PRP) using either pattern scan laser (PASCAL) or navigated laser photocoagulation (NAVILAS). METHODS: Patients diagnosed with PDR were randomly assigned to undergo either PASCAL or NAVILAS photocoagulation treatment. PRP was performed using the multi-shot mode with a spot size of 200-400 µm and a pulse duration of 30 ms to obtain a white-grayish spot on the retina. Parameters were identical in both procedures. After 30 min of PRP application, patients were asked to verbally describe their pain perception as either "none," "mild," "moderate," "severe," or "very severe" using a verbal rating scale (VRS) and visual analog scale (VAS) by indicating a score from "0" to "10," representing the severity of pain from "no pain" to "severe pain." RESULTS: A total of 60 eyes of 60 patients (20 females and 40 males) diagnosed with PDR were treated. The mean age of patients was 62.22 ± 9.19 years, and the mean diabetes duration was 195.47 ± 94.54 months. The mean number of laser spots delivered during PRP was 389.47 ± 71.52 in the NAVILAS group and 392.70 ± 54.33 in the PASCAL group (p=0.57). The difference in pain responses between patients in the NAVILAS and PASCAL groups was significant with regard to the mean VRS (1.10 ± 0.67 and 1.47 ± 0.69, respectively; p=0.042) and mean VAS (2.13 ± 1.17 and 2.97 ± 1.35, respectively; p=0.034) scores. CONCLUSIONS: Pain responses in patients undergoing PRP with a 30-ms pulse duration were significantly milder in the NAVILAS group than in the PASCAL group.

Comparison of pain scores between patients undergoing panretinal photocoagulation using navigated or pattern scan laser systems / Comparação de graduação de dor entre os pacientes submetidos à panfotocoagulação usando sistemas de laser navegado ou de padrão de varredura

ABSTRACT Purpose: To compare the pain responses of patients with proliferative diabetic retinopathy (PDR) undergoing panretinal photocoagulation (PRP) using either pattern scan laser (PASCAL) or navigated laser photocoagulation (NAVILAS). Methods: Patients diagnosed with PDR were randomly assigned to undergo either PASCAL or NAVILAS photocoagulation treatment. PRP was performed using the multi-shot mode with a spot size of 200-400 µm and a pulse duration of 30 ms to obtain a white-grayish spot on the retina. Parameters were identical in both procedures. After 30 min of PRP application, patients were asked to verbally describe their pain perception as either "none," "mild," "moderate," "severe," or "very severe" using a verbal rating scale (VRS) and visual analog scale (VAS) by indicating a score from "0" to "10," representing the severity of pain from "no pain" to "severe pain." Results: A total of 60 eyes of 60 patients (20 females and 40 males) diagnosed with PDR were treated. The mean age of patients was 62.22 ± 9.19 years, and the mean diabetes duration was 195.47 ± 94.54 months. The mean number of laser spots delivered during PRP was 389.47 ± 71.52 in the NAVILAS group and 392.70 ± 54.33 in the PASCAL group (p=0.57). The difference in pain responses between patients in the NAVILAS and PASCAL groups was significant with regard to the mean VRS (1.10 ± 0.67 and 1.47 ± 0.69, respectively; p=0.042) and mean VAS (2.13 ± 1.17 and 2.97 ± 1.35, respectively; p=0.034) scores. Conclusions: Pain responses in patients undergoing PRP with a 30-ms pulse duration were significantly milder in the NAVILAS group than in the PASCAL group.

RESUMO Objetivo: Comparar as respostas de dor de pacientes com retinopatia diabética proliferativa (PDR) submetidos à panfotocoagulação retiniana (PRP) usando laser de padrão de varredura (PASCAL) ou fotocoagulação navegada a laser (NAVILAS). Métodos: Pacientes com diagnóstico de PDR foram aleatoriamente designados para submeter-se ao tratamento de fotocoagulação com PASCAL ou NAVILAS. A PRP foi realizada no modo "multi-shot" com diâmetro do laser de 200-400 µm e duração do pulso de 30 ms, utilizados para se obter uma mancha branca-acinzentada na retina. Os parâmetros foram idênticos em ambos os procedimentos. Após 30 minutos da PRP, os pacientes foram solicitados a descrever verbalmente a sua percepção da dor como quer "nenhuma," "leve," "moderada," "intensa" ou "dor muito intensa" por meio de uma escala de avaliação verbal (VRS) e também por meio de uma escala visual analógica (VAS), indicando uma pontuação de "0" a "10" representando a intensidade da dor de "nenhuma dor" a "dor intensa." Resultados: Um total de 60 olhos de 60 pacientes (20 mulheres e 40 homens) com diagnóstico de PDR foram tratados. A média de idade dos pacientes foi de 62,22 ± 9,19 anos e a média de duração da diabete foi 195.47 ± 94,54 meses. O número médio de pulsos de laser emitidos durante a PRP foi 389,47 ± 71,52 no grupo NAVILAS e 392,70 ± 54,33 no grupo PASCAL (p=0,57). A diferença nas respostas de dor entre os pacientes nos grupos NAVILAS e PASCAL foi significativa em relação às médias de VRS (1,10 ± 0,67 e 1,47 ± 0,69; p=0,042) e VAS (2,13 ± 1,17 e 2,97 ± 1,35; p=0,034). Conclusões: As respostas de dor em pacientes submetidos à PRP com pulsos de 30 ms de duração foram significativamente menores nos pacientes do grupo NAVILAS em relação ao grupo PASCAL.