scholarly journals Eyes that Do Not Meet the Eligibility Criteria of Clinical Trials on Age-Related Macular Degeneration: Proportion of the Real-World Patient Population and Reasons for Exclusion

2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Jae Hui Kim ◽  
Jong Woo Kim ◽  
Chul Gu Kim
Keyword(s):  
Clinical Trials ◽  
Visual Acuity ◽  
Real World ◽  
Age Related Macular Degeneration ◽  
Subretinal Hemorrhage ◽  
Neovascular Amd ◽  
Eligibility Criteria ◽  
Type 3 Neovascularization ◽  
Age Related ◽  
Type 3

Background. To evaluate the proportion of eyes that do not meet the eligibility criteria of clinical trials on neovascular age-related macular degeneration (AMD) and the reasons for exclusion. Methods. This retrospective, observational study included 512 eyes of 463 patients diagnosed with treatment-naïve neovascular AMD. The proportion of eyes that did not meet the eligibility criteria of the Vascular Endothelial Growth Factor Trap-Eye: Investigation of Efficacy and Safety in Wet AMD (VIEW) studies were evaluated. The two most common reasons for exclusion were also evaluated in each subtype of neovascular AMD (typical neovascular AMD, polypoidal choroidal vasculopathy (PCV), and type 3 neovascularization). Results. Among the 512 eyes, 229 (44.7%) did not meet the eligibility criteria. In all the included eyes, the most common reasons for exclusion were good or poor visual acuity (169 eyes, 33.0%), followed by the presence of subretinal hemorrhage (47 eyes, 9.5%). Moreover, good or poor visual acuity was the most common reason for exclusion in all three subtypes of neovascular AMD. The second most common reason was a fovea-involving scar or fibrosis in typical neovascular AMD, subretinal hemorrhage in PCV, and other vascular diseases affecting the retina in type 3 neovascularization. Conclusions. Among the included cases, 44.7% did not meet the eligibility criteria for VIEW study, suggesting that the conclusion derived from clinical trials may not directly reflect the real-world outcomes. Additionally, the reasons for ineligibility differed among the different subtypes of neovascular AMD.

OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY OF TYPE 3 NEOVASCULARIZATION SECONDARY TO AGE-RELATED MACULAR DEGENERATION

Retina ◽  
2015 ◽  
Vol 35 (11) ◽  
pp. 2229-2235 ◽  
Author(s):  
Laura Kuehlewein ◽  
Kunal K. Dansingani ◽  
Talisa E. de Carlo ◽  
Marco A. Bonini Filho ◽  
Nicholas A. Iafe ◽  
...  
Keyword(s):  
Optical Coherence Tomography ◽  
Macular Degeneration ◽  
Optical Coherence Tomography Angiography ◽  
Age Related Macular Degeneration ◽  
Optical Coherence ◽  
Type 3 Neovascularization ◽  
Age Related ◽  
Type 3

scholarly journals Fibrovascular pigment epithelial detachment in eyes with subretinal hemorrhage secondary to neovascular AMD or PCV: a morphologic predictor associated with poor treatment outcomes

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Jae Hui Kim ◽  
Joo Yeon Kim ◽  
Dong Won Lee ◽  
Chul Gu Kim ◽  
Jong Woo Kim
Keyword(s):  
Treatment Outcomes ◽  
Treatment Strategies ◽  
Age Related Macular Degeneration ◽  
Subretinal Hemorrhage ◽  
Pigment Epithelial Detachment ◽  
Neovascular Amd ◽  
Pigment Epithelial ◽  
Age Related ◽  
Poor Treatment ◽  
The Mean

Abstract To evaluate the influence of fibrovascular pigment epithelial detachment (FVPED) on treatment outcomes in eyes with subretinal hemorrhage secondary to neovascular age-related macular degeneration (AMD) and polypoidal choroidal vasculopathy (PCV). This retrospective study included 83 eyes diagnosed with fovea-involving submacular hemorrhage secondary to neovascular AMD or PCV. All the patients were treated with intravitreal anti-vascular endothelial growth factor. Eyes showing definite FVPED, which involves the subfoveal region, were included in the FVPED group. Eyes without subfoveal PED, shallow irregular PEDs, or serous/hemorrhagic PED were stratified to the non-FVPED group. The best-corrected visual acuity (BCVA) at diagnosis, at 3 months, at 12 months, and lesion re-activation after initial treatment were compared between the two groups. The mean size of hemorrhage was 8.6 ± 7.6 disc diameter areas. In the FVPED group, the mean logarithm of minimal angle of resolution BCVA was 1.11 ± 0.49 at diagnosis, 0.89 ± 0.58 at 3 months, and 1.05 ± 0.63 at 12 months. In the non-FVPED group, the values were 0.97 ± 0.56, 0.56 ± 0.55, and 0.45 ± 0.50, respectively. The BCVA at 3 months (P = 0.036) and at 12 months (P < 0.001) was significantly worse in the FVPED group than in the non-FVPED group. In addition, the incidence of lesion reactivation was greater in the FVPED group (83.3%) than in the non-FVPED group (38.5%) (P < 0.001). The presence of subfoveal FVPED was associated with a high incidence of lesion re-activation and poor treatment outcomes in eyes with subretinal hemorrhage. This result suggests that different treatment strategies are needed between eyes with and without FVPED.

scholarly journals Limited Treatment Response during Follow-up after Switching to Aflibercept in Neovascular Age-related Macular Degeneration

2021 ◽  
Vol 62 (9) ◽  
pp. 1218-1226
Author(s):  
Gon Soo Choe ◽  
Jong Woo Kim ◽  
Chul Gu Kim ◽  
Jae Hui Kim
Keyword(s):  
Visual Acuity ◽  
Retrospective Study ◽  
Macular Degeneration ◽  
Treatment Response ◽  
Visual Outcome ◽  
Age Related Macular Degeneration ◽  
Neovascular Amd ◽  
Age Related ◽  
The Mean

Purpose: To investigate the limited response to aflibercept after switching to aflibercept in neovascular age-related macular degeneration (AMD). Methods: This retrospective study included 70 eyes with neovascular AMD that were initially treated with ranibizumab and then switched to aflibercept. The incidence and timing of the limited response to aflibercept were identified and visual outcome was compared between eyes with and without limited response. In addition, factors predictive of limited response were analyzed. Results: A limited response to aflibercept was noted in approximately 1/5 of the patients who underwent switching to aflibercept in neovascular AMD. Switching to aflibercept was performed at a mean of 16.2 ± 12.7 months after diagnosis. During the mean 34.7 months of follow-up after switching, limited response was noted in 15 eyes (21.4%) at a mean of 22.0 ± 13.9 months after switching. The degree of reduction in visual acuity was mean logMAR 0.34 ± 0.41 in eyes with limited response and mean 0.06 ± 0.20 in eyes without (p = 0.002). In addition, the duration between the diagnosis and the switching was shorter (p = 0.012), and the number of ranibizumab injections before switching was lower (p = 0.016) in eyes with limited response than in eyes without. Conclusions: Patients who showed limited response to aflibercept after switching to aflibercept showed a worse visual outcome. The probability of having a limited response is higher when the switching is performed earlier.

scholarly journals Neovascular AMD: Where do we go from here?

2016 ◽  
Vol 7 (2) ◽  
pp. 97-102
Author(s):  
Mark R Barakat ◽  
Pravin U Dugel
Keyword(s):  
Vascular Endothelial Growth Factor ◽  
Visual Acuity ◽  
Growth Factor ◽  
Age Related Macular Degeneration ◽  
Vascular Endothelial ◽  
Neovascular Amd ◽  
Age Related ◽  
Monthly Injection ◽  
Injection Regimen ◽  
Endothelial Growth Factor

In the age of anti-vascular endothelial growth factor (VEGF) therapy, we are fortunate as clinicians to have three great options in the treatment of neovascular age-related macular degeneration (AMD). Yet we still face a dilemma, in that we lack a truly sustainable treatment strategy. For various reasons, as a group we cannot maintain a monthly injection regimen for patients and are giving far less, approximately half of that, be it bevacizumab, ranibizumab, or aflibercept (Holekamp et al, 2014). Unfortunately, this comes at a cost: changing from monthly to as-needed injections has been associated with a decline in visual acuity almost back down to baseline (Singer et al, 2012; Silva et al, 2013). 

Comparison of Visual Acuity and Central Macular Thickness in Neovascular Age-related Macular Degeneration Patients with Subretinal and Intraretinal Fluid Treated with Intravitreal Bevacizumab

2019 ◽  
Vol 45 (1) ◽  
pp. 20
Author(s):  
Novia Rahayu ◽  
Elvioza Elvioza ◽  
Aria Kekalih
Keyword(s):  
Visual Acuity ◽  
Macular Degeneration ◽  
Intravitreal Bevacizumab ◽  
Age Related Macular Degeneration ◽  
Loading Dose ◽  
Central Macular Thickness ◽  
Neovascular Amd ◽  
Age Related ◽  
Bevacizumab Treatment ◽  
Intraretinal Fluid

Purpose: To compare visual acuity (VA) and central macular thickness (CMT) outcome of loading dose intravitreal bevacizumab treatment between neovascular AMD patients with character of predominant subretinal and intraretinal fluid. Methods: Prospective study of loading dose intravitreal bevacizumab treated age-related macular degeneration, of which has a baseline macular morphology of subretinal or intraretinal fluid. VA, CMT, and their changes were evaluated during and after loading dose was completed. Results: Thirty eight eyes (38 patients, mean age 66,95 years) were enrolled. 20 eyes were in subretinal fluid (SRF group) and 18 intraretinal fluid (IRF) group. Mean VA at baseline eventually was significantly different where SRF group (56,41 letters) were better than IRF group (43,72 letters). No statistically significant difference of mean VA change or CMT change between group, however VA in SRF group remained higher and CMT in SRF group were lower than IRF group. Conclusion: Neovascular AMD, with both SRF and IRF at baseline, benefits from loading dose intravitreal bevacizumab treatment although mean visual acuity and mean central retinal thickness are better in those with SRF.

Nascent Type 3 Neovascularization in Age-Related Macular Degeneration

2018 ◽  
Vol 2 (11) ◽  
pp. 1097-1106 ◽  
Author(s):  
Riccardo Sacconi ◽  
David Sarraf ◽  
Sean Garrity ◽  
K. Bailey Freund ◽  
Lawrence A. Yannuzzi ◽  
...  
Keyword(s):  
Macular Degeneration ◽  
Age Related Macular Degeneration ◽  
Type 3 Neovascularization ◽  
Age Related ◽  
Type 3

scholarly journals Can the Onset of Neovascular AMD be an Acceptable Endpoint for Prophylactic Clinical Trials?

2020 ◽  
Author(s):  
Luísa S.M. Mendonça ◽  
Emily S. Levine ◽  
Nadia K. Waheed
Keyword(s):  
Clinical Trials ◽  
Macular Degeneration ◽  
Primary Endpoint ◽  
Current Practice ◽  
Age Related Macular Degeneration ◽  
Neovascular Amd ◽  
The Past ◽  
Age Related ◽  
The Ideal

Many studies over the past twenty years have pursued the goal of preventing or deferring progression from early and intermediate age-related macular degeneration (AMD) to advanced AMD. The onset of neovascular AMD has been used as a primary endpoint in some prophylactic clinical trials because it is easy to assess and relatively well defined. Nevertheless, the use of this endpoint for assessing progression of AMD lacks validation. The aims of this manuscript are to review the current practice of clinical trials on the prevention of progression of early or intermediate AMD to neovascular AMD – so called prophylactic trials, and to identify ongoing efforts to standardize endpoints and select the ideal population for such studies.  

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