Treatment Efficacy and Compliance in Patients with Diabetic Macular Edema Treated with Ranibizumab in a Real-Life Setting

Purpose. To assess real-life efficacy of ranibizumab and treatment compliance of patients with vision loss secondary to diabetic macular edema (DME). Methods. A retrospective study was conducted in DME patients treated with ranibizumab. Patients were monitored every 4 weeks for visual acuity (VA) and central retinal thickness (CRT) by SD-OCT. All patients received a loading dose of 3 monthly injections followed by retreatments on an as-needed basis. The primary endpoint was the change in VA at M12. Patient compliance to the follow-up and the correlation between the injection number and VA were also investigated. Compliance was compared to that of neovascular age-related macular degeneration (nAMD) patients. Results. Seventy-two eyes of 55 consecutive DME patients were included. At baseline, the mean VA was 56.5 letters and CRT was 470 μm. At M12, the mean VA was 63.4 letters (p<0.0001), 31.1% of patients had a VA > 70 letters, the mean VA change was +6.9 letters, and the mean CRT was 361.9 μm (p=0.0001) after a mean number of 5.33 intravitreal injections. In patients who received ≥7 injections, the VA gain and final VA were significantly higher than in patients who received <7 injections. At M12, 25.45% of DME patients were lost to follow-up versus 16.8% of nAMD patients (n=55). Discussion/Conclusion. Our study confirms the real-life efficacy of ranibizumab in DME at M12 and the need for a large number of injections to achieve better visual outcomes. We also showed a trend to a lower compliance in diabetic versus nAMD patients.

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Diabetic Macular Edema Patients with Poor Baseline Visual Acuity Treated with Ranibizumab in Real Life and Optical Coherence Tomography Based Predictor Factors for Visual Outcomes

Journal of Health and Allied Sciences NU ◽

10.1055/s-0040-1708747 ◽

2018 ◽

Vol 08 (02) ◽

pp. 008-014

Author(s):

Abdullah Ozkaya ◽

Mehmet Ozveren ◽

Okkes Baz ◽

Hatice Nur Tarakcioglu ◽

Korhan Fazil ◽

...

Keyword(s):

Visual Acuity ◽

Macular Edema ◽

Diabetic Macular Edema ◽

Vision Loss ◽

Real Life ◽

Life Outcomes ◽

Stable Vision ◽

The Mean ◽

Baseline Visual Acuity

Abstract Purpose: We aimed to evaluate the real life outcomes of ranibizumab in the treatment of diabetic macular edema (DME) patients with a baseline visual acuity<0.05 in decimals. Methods: Newly diagnosed DME patients with a visual acuity ≤0.05, treated with ranibizumab monotherapy, and completed a follow-up time of 12 months were included retrospectively. Patients were evaluated in regards to change in best corrected visual acuity (BCVA) and central retinal thickness, and the total visit and injection numbers. Results: A total of 24 eyes of 24 patients were included. Mean BCVA at baseline, month 3, 6, 9, and 12 was, 0.04±0.01, 0.12±0.12, 0.12±0.11, 0.17±0.19, and 0.21±0.21 (p<0.05 for all), respectively. One eye (4.2%) had VA loss of ≥3 lines, and six eyes (25.0%) had stable vision (loss of <3 line, or remained stable, or gained <1 lines), and 17 eyes (70.8%) had VA gain of ≥3 lines at month 12.The mean visit number at month 12 was 4.8±1 and the mean injection number was 4.0 ±1.4. Conclusion: Ranibizumab seemed to be effective in the treatment of DME patients with a low visual acuity in real life.

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Aflibercept in real-life for the treatment of age-related macular degeneration using a treat and extend protocol: The Armada study

European Journal of Ophthalmology ◽

10.1177/11206721211005703 ◽

2021 ◽

pp. 112067212110057

Author(s):

Pierre Gascon ◽

Prithvi Ramtohul ◽

Charles Delaporte ◽

Sébastien Kerever ◽

Danièle Denis ◽

...

Keyword(s):

Macular Degeneration ◽

Real Life ◽

Age Related Macular Degeneration ◽

Cumulative Number ◽

Treat And Extend ◽

Treatment Interval ◽

Age Related ◽

Treatment Naïve ◽

The Mean

Purpose: To report the visual and anatomic outcomes in treatment-naïve neovascular age-related macular degeneration (nAMD) patients treated with aflibercept under a standardized Treat and Extend (T&E) protocol for up to 3 years of follow-up in “real-life” practice. Methods: This retrospective, observational, multicenter study included patients with treatment-naïve nAMD and at least 12 months of follow-up. T&E regimen adjustment was initiated after loading phase. At each visit best-corrected visual acuity (BCVA) and optical coherence tomography parameters were performed. Results: One hundred and thirty-six eyes of 115patients had at least 1 year of follow-up with 114 and 82 eyes completing at least 2 and 3 years of follow-up, respectively (mean follow-up duration: 2.7 ± 1.3 years). Mean age was 78.6 ± 8.6 years old and 52% were women. Mean BCVA increased from 60.6 ± 18.7 letters at diagnosis to 66.9 ± 16.2 letters at 1 year (+6.3 letters, p = 0.003) and remained stable throughout the follow-up period (63.1 ± 20.3 letters (+2.5, p = 0.1) and 64.0 ± 20.1 letters (+3.4, p = 0.27) at 2 and 3 years, respectively). The mean central retinal thickness decreased significantly from 358.2 ± 87.9 µm at baseline to 302 ± 71.7 µm at 12 months and maintained stable after 36 months of follow-up (297.1 ± 76 µm, p < 0.0001). Mean number of injections was 6.6 ± 2.2, 4.8 ± 1.9, and 5.6 ± 1.7 at 1, 2, and 3 years, respectively. Mean cumulative number of 16.4 ± 5.6 injections after 3 years. Mean treatment interval was 6.8 ± 2.5 weeks at 1 year. Eight-week and 12-week treatment interval were achieved in 59.5% and 19.1%, 65.8%, and 36.8% and 69.5% and 41.5% at 1, 2, and 3 years, respectively. Conclusions: Our study demonstrated that intravitreal injections of aflibercept initiated under a standardized T&E for patients with treatment-naïve nAMD allow for significant visual improvement at 12 months, which was maintained over a 3-year follow-up period.

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Outcome of anti-vascular endothelial growth factor therapy for neovascular age-related macular degeneration in real-life setting

British Journal of Ophthalmology ◽

10.1136/bjophthalmol-2017-311055 ◽

2017 ◽

Vol 102 (7) ◽

pp. 959-965 ◽

Cited By ~ 13

Author(s):

Maria Kataja ◽

Pekko Hujanen ◽

Heini Huhtala ◽

Kai Kaarniranta ◽

Anja Tuulonen ◽

...

Keyword(s):

Vascular Endothelial Growth Factor ◽

Growth Factor ◽

Real Life ◽

Age Related Macular Degeneration ◽

Vascular Endothelial ◽

Anti Vegf ◽

Age Related ◽

Real Life Setting ◽

The Mean ◽

Endothelial Growth Factor

AimsTo evaluate outcome of anti-vascular endothelial growth factor (VEGF) therapy for the treatment of neovascular age-related macular degeneration (nAMD) in the real-life setting and to compare incidence of ocular serious adverse events (SAE) after injections administered by nurses and physicians.MethodsRetrospective, single-centre study. Medical records of patients receiving anti-VEGF treatment for nAMD between 2008 and 2013 with three-loading-dose regimen were evaluated. Outcome measures were baseline visual acuity (VA), change in VA, number of intravitreal injections, incidence of ocular SAE and patients’ baseline characteristics affecting VA change. In addition, the number of injections per 1000 citizens living in the serving area and per individuals over 65 years old were estimated.Results1349 eyes in 1117 patients received a total of 11 562 intravitreal anti-VEGF injections. Twenty-one per cent of patients received treatment for both eyes. The mean baseline Snellen VA was 0.32. The mean change of VA from baseline was +2, +2 and ±0 Early Treatment Diabetic Retinopathy Study letters and the mean numbers of injections were 5.7, 4.7 and 4.9 at years 1, 2 and 3, respectively. There was a negative correlation between baseline VA and change of VA. Incidence of endophthalmitis was 0.086%. No difference in the incidence of ocular SAE was identified between injections given by nurses or by physicians. The number of intravitreal injections per all citizens was 9 per 1000 inhabitants and 45 per 1000 inhabitants over 65 years.ConclusionThe VA was maintained at the baseline level (±0 letters) with the mean of 15.3 anti-VEGF injections in real-world clinical practice during 3-year follow-up.

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Treatment patterns in patients with age-related macular degeneration and diabetic macular edema: A real-world claims analysis in Dubai

PLoS ONE ◽

10.1371/journal.pone.0254569 ◽

2021 ◽

Vol 16 (7) ◽

pp. e0254569

Author(s):

Igor Kozak ◽

Avinash Gurbaxani ◽

Ammar Safar ◽

Prasan Rao ◽

Amal Masalmeh ◽

...

Keyword(s):

Macular Degeneration ◽

Macular Edema ◽

Diabetic Macular Edema ◽

Real World ◽

Treatment Patterns ◽

Age Related Macular Degeneration ◽

Treatment Frequency ◽

Anti Vegf ◽

Age Related

Objectives To characterize the pattern of approved anti-vascular endothelial growth factor (VEGF) treatments among patients with neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) in the United Arab Emirates (UAE). Method This was a retrospective, nonrandomized, observational cohort analysis of the Dubai Real-world Claims Database with a 360-day follow-up period. Adult patients diagnosed with nAMD or DME treated with ranibizumab or aflibercept for the first time were included. The primary objective was to evaluate anti-VEGF treatment patterns with respect to the proportion of patients receiving ranibizumab and aflibercept for nAMD and DME separately. Results Of the 451 patients included in the final study cohort, 83.6% and 16.4% had a diagnosis of DME (ranibizumab: 48.5%; aflibercept: 51.5%) and nAMD (ranibizumab: 40.5%; aflibercept: 59.5%), respectively, at baseline. Treatment frequency of ranibizumab/aflibercept was similar for nAMD (mean: 2.4/2.9 injections; p = 0.2389) with fewer injections in the ranibizumab cohort for DME (mean: 1.9/2.5 injections; p = 0.0002). Most patients received ≤3 anti-VEGF injections during the 360-day follow-up period. The time between consecutive treatments was large (nAMD: 73.6 days/10.5 weeks; DME: 80.5 days/11.5 weeks). Approximately 10%–13.5% of patients switched their anti-VEGF therapy. Most patients (83.8%) had a diabetes diagnosis during the follow-up period. Conclusions This real-world study provides an initial understanding of anti-VEGF treatment patterns in patients with nAMD and DME in the UAE. Treatment frequency of the 2 anti-VEGF agents assessed was similar in both patient populations. Both treatments were infrequently administered with large dosing intervals.

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Vitrectomy for diabetic macular edema and the relevance of external limiting membrane

BMC Ophthalmology ◽

10.1186/s12886-021-02095-y ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Ivastinovic Domagoj ◽

Haas Anton ◽

Weger Martin ◽

Seidel Gerald ◽

Mayer-Xanthaki Christoph ◽

...

Keyword(s):

Macular Edema ◽

Diabetic Macular Edema ◽

Visual Outcome ◽

Internal Limiting Membrane ◽

Age Related Macular Degeneration ◽

External Limiting Membrane ◽

Ilm Peeling ◽

Spectral Domain Oct ◽

Age Related

Abstract Purpose To evaluate the relevance of external limiting membrane (ELM) on the visual and morphological results in eyes with diabetic macular edema (DME) that underwent pars plana vitrectomy (PPV) with epiretinal membrane (ERM) and internal limiting membrane (ILM) peeling. Methods Medical records of patients with DME who underwent PPV at our unit between January 2017 and December 2019 were reviewed. We assessed preoperative and postoperative best-corrected visual acuity (BCVA), central macular thickness (CMT) using spectral domain OCT (optical coherence tomography). Exclusion criteria were previous PPV; incomplete data; concomitant diseases including retinal vein occlusion, age-related macular degeneration, uveitis; and a follow-up of less than 12 months. The surgeries were performed using 23- or 27-gauge vitrectomy. The ELM was graded depending on its configuration (grade 0 = intact, grade 1 to 3: disruption of varying extent). Results Ninety-nine eyes were enrolled. The postoperative follow up averaged 23.7 months. The preoperative and final BCVA averaged 0.71 ± 0.28 and 0.52 ± 0.3 logMAR, respectively (p = 0.002). The CMT averaged 515.2 ± 209.1 μm preoperatively and 327 ± 66.1 μm postoperatively (p = 0.001). Eyes with intact ELM (n = 8) had a significantly better BCVA compared to those with ELM disruption (0.28 ± 0.14 vs. 0.7 ± 0.25 logMAR, p = 0.01). The final CMT was similar among the groups (intact ELM: 317 ± 54.6 μm; ELM disruption: 334 ± 75.2, p = 0.31). Conclusions PPV with ERM and ILM peeling is an effective treatment of DME. Eyes with intact ELM preoperatively had a significantly better final visual outcome. To maximize the benefit for patients with DME we recommend early PPV as long as ELM is intact.

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Quality-Adjusted Life Years in Macular Edema: The Benefit of Anti-VEGF Agents in a Tertiary Center in Greece

10.21203/rs.3.rs-695361/v1 ◽

2021 ◽

Author(s):

Nikolaos Theodore Voutsas ◽

Eleni Papageorgiou ◽

Alexandra Tantou ◽

Evangelia Tsironi ◽

Maria Kotoula

Keyword(s):

Macular Edema ◽

Time Horizon ◽

Vision Loss ◽

Hospital Setting ◽

Age Related Macular Degeneration ◽

Anti Vegf ◽

Age Related ◽

Life Years ◽

Tertiary Center

Abstract Introduction: Diabetic macular edema (DME), wet age-related macular degeneration (AMD) and macular edema due to central retinal vein occlusion (CRVO) are leading causes of vision loss, currently managed with anti-vascular endothelial growth factor injections (anti-VEGF). Aim of this study was to calculate QALYs in patients with DME, AMD and CRVO treated with anti-VEGF agents (QALYs+) in a Greek tertiary hospital setting and compare them to theoretical QALYs that the patients would have without treatment (QALYs-). Material and Methods: The study included 143 treatment-naive patients with macular edema due to DM (n=57), AMD (n=79) and CRVO (n=7), who received anti-VEGF injections as monotherapy according to the Treat-and-Extend (T&E) protocol. The anti-VEGF agents were ranibizumab and aflibercept in equivalent fractions. QALYs where calculated by the formula QALY = Utility Value * Time, where “time” refers to the follow-up period of the study. For QALYs-, we assumed that visual acuity remained unchanged during this period.Results: Mean follow-up time was 1+1.3 years in the DME group, 1.3 + 1.2 years in the AMD group and 0.5 +1 years in the CRVO group. For patients with DME, QALYs- were 0.75, and QALYs+ were 0.78 (QALY difference +0.033, p=0.439). For patients with AMD, QALYs- were 0.95 and QALYs+ were also 0.95 (QALY difference 0, p=0.45). QALYs- of patients with CRVO were 0.77, and QALYs+ were 0.80 (QALY difference +0.032, p=0.09).Discussion/Conclusion: QALYs+ were identical to QALYs- in patients with AMD and QALYs+ were minimally higher than QALYs- in patients with DME and CRVO in this specific Greek setting for a time horizon between 0.5 and 1.3 years. Possible explanations are the short time horizon used in this analysis and the inclusion of data from the better-seeing eye (BSE).

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Visual Outcomes after Anti-VEGF Therapy for Exudative Age-Related Macular Degeneration in a Real-Life Setting

Klinische Monatsblätter für Augenheilkunde ◽

10.1055/a-1403-3224 ◽

2021 ◽

Vol 238 (04) ◽

pp. 396-402

Author(s):

Andrea R. Wenkstern ◽

Christophe Valmaggia

Keyword(s):

Macular Degeneration ◽

Real Life ◽

Case Series ◽

Age Related Macular Degeneration ◽

Serious Adverse Events ◽

Visual Outcomes ◽

Anti Vegf ◽

Age Related ◽

Real Life Setting

Abstract Background To report visual outcomes of anti-vascular endothelial growth factor (anti-VEGF) therapy for exudative age-related macular degeneration (AMD) in a real-life setting. Patients and Methods Retrospective case series of consecutive patients treated with either ranibizumab and/or aflibercept for monolateral or bilateral exudative AMD. A physician established the indication for treatment and administered the injections. An independent physician confirmed the indication for primary treatment. A Pro Re Nata and a Treat and Extend regimen were used. Assessment of subretinal and/or intraretinal fluid, retinal hemorrhage and increase in pigment epithelial detachment served as criteria for further treatment decisions. Visual acuity (VA) was measured in ETDRS letters at each examination and then analyzed using a specialized software. Evolution of mean VA was considered for all study eyes and subgroups of eyes with an initial VA ≥ 70 ETDRS letters (subgroup 1) and ≤ 69 ETDRS letters (subgroup 2). Results A total of 102 eyes of 76 patients (30 men, mean age 75.9 years; 46 women, mean age 81.5 years) were included. Subgroup 1 consisted of 47 eyes, and subgroup 2 of 55 eyes. Mean follow-up was 55 months (range 6 to 150 months). For the entire collective as for subgroups 1 and 2, the mean VA was 64, 77, or 51 ETDRS letters at baseline. Mean VA improved at month 12 (68, 80, or 58 ETDRES letters) and then slowly decreased over time until month 150 (62, 72, or 54 ETDRS letters). Maximum improvement of + 5, + 3, or, + 9 ETDRS letters occurred after 9, 8, or 10 months of follow-up. Atrophy and fibrosis were mainly responsible for VA decrease. Ten serious adverse events were reported to Swissmedic: two cases of cardiovascular events and eight cases of intraocular inflammation. Conclusions Anti-VEGF therapy carried out in a real-life setting shows good VA outcomes with a favorable safety profile.

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Intravitreal Ranibizumab in Daily Clinical Practice for Age-Related Macular Degeneration: Treatment of Exudative Age-Related Macular Degeneration in Real Life

Ophthalmologica ◽

10.1159/000430470 ◽

2015 ◽

Vol 234 (1) ◽

pp. 26-32 ◽

Cited By ~ 6

Author(s):

Agathe Cazet-Supervielle ◽

Julien Gozlan ◽

Séverin Cabasson ◽

Michèle Boissonnot ◽

Hélène Manic ◽

...

Keyword(s):

Macular Degeneration ◽

Real Life ◽

Age Related Macular Degeneration ◽

Diagnosis And Treatment ◽

Optic Coherence Tomography ◽

Intravitreal Ranibizumab ◽

Age Related ◽

The Mean ◽

Practice Methods

Purpose: To describe the anatomical and functional outcomes in patients with exudative age-related macular degeneration (AMD) undergoing ranibizumab therapy in real-life practice. Methods: This is a retrospective analysis of patients with exudative AMD treated with ranibizumab. Visual acuity (VA) and optic coherence tomography characteristics at baseline and at the end of the follow-up, clinical forms of the disease, delay between diagnosis and treatment as well as the number of follow-up visits and of intravitreal injections were collected. Results: One hundred and seventy-nine patients (220 eyes) were followed up during a mean of 24 months. The mean delay between diagnosis and treatment was 20.3 days (SD ±16.8). VA stabilization was observed in 46.4% of eyes, 21.7% of eyes gained ≥15 ETDRS (Early Treatment Diabetic Retinopathy Study) letters and 31.9% lost ≥15 ETDRS letters. The mean central retinal thickness decreased from 380.6 μm at baseline to 295.6 µm at the final examination. A lower baseline VA score was associated with a greater gain of letters (OR 1.04, 95% CI 1.02-1.06; p < 0.001). Conclusion: Shortening the delays in diagnosis appears to be a key point in real-life situations.

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Four-year outcomes of aflibercept treatment for neovascular age-related macular degeneration: Results from real-life setting

European Journal of Ophthalmology ◽

10.1177/1120672120938565 ◽

2020 ◽

pp. 112067212093856

Author(s):

Marko Lukic ◽

Maria Eleftheriadou ◽

Robin D Hamilton ◽

Ranjan Rajendram ◽

Kajo Bucan ◽

...

Keyword(s):

Macular Degeneration ◽

Cohort Analysis ◽

Real Life ◽

Epidemiological Data ◽

Age Related Macular Degeneration ◽

Age Related ◽

Intravitreal Aflibercept ◽

The Mean

Background: To assess long-term structural and functional outcomes of intravitreal aflibercept (Eylea®) treatment for neovascular macular degeneration (nAMD) in a real-word setting. Design and methods: This was a retrospective, single-centre, non-randomized interventional cohort analysis. Data from treatment-naive patients with nAMD funded for treatment with intravitreal aflibercept in the period between 1 September 2013 and 28 February 2014 and who finished 4-year follow-up entered the analysis. Epidemiological data, visual acuity (VA) measured on ETDRS charts and injection numbers were recorded. Spectral domain optical coherence tomography (SD-OCT) data including presence or absence of macular fluid and automated central subfield macular thickness (CSMT) at year 1, 2, 3 and 4 were also recorded. Results: Ninety-four eyes of 89 patients finished 4-year follow-up. The mean number of aflibercept injections received over 4 years was 19.3. At baseline, the mean VA (SD) (Snellen) was 54.1 ± 15.5 (20/100) ETDRS letters whilst the mean CSM (SD) was 296 ± 81 µm. At 4 years, the mean VA (SD) (Snellen) was 60.4 ± 20.0 (20/63) ETDRS letters ( p < 0.0001). Mean CSMT (SD) was 218 ± 79 μm ( p < 0.0001). Thirty-three percent of eyes gained ⩾15 ETDRS letters at end of 4 years, and 66 (70%) eyes had no macular fluid at the end of the follow-up. Conclusion and relevance: The results suggest that good long-term morphological and functional treatment outcomes can be achieved using intravitreal aflibercept for nAMD in a real-life clinical setting.

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