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.  

scholarly journals Future Perspectives of Therapeutic, Diagnostic and Prognostic Aptamers in Eye Pathological Angiogenesis

Cells ◽  
2021 ◽  
Vol 10 (6) ◽  
pp. 1455
Author(s):  
Emilio Iturriaga-Goyon ◽  
Beatriz Buentello-Volante ◽  
Fátima Sofía Magaña-Guerrero ◽  
Yonathan Garfias
Keyword(s):  
Clinical Trials ◽  
Macular Degeneration ◽  
Small Molecules ◽  
Inflammatory Diseases ◽  
Age Related Macular Degeneration ◽  
Future Perspectives ◽  
Whole Cells ◽  
Pathological Angiogenesis ◽  
Age Related ◽  
Viral Particles

Aptamers are single-stranded DNA or RNA oligonucleotides that are currently used in clinical trials due to their selectivity and specificity to bind small molecules such as proteins, peptides, viral particles, vitamins, metal ions and even whole cells. Aptamers are highly specific to their targets, they are smaller than antibodies and fragment antibodies, they can be easily conjugated to multiple surfaces and ions and controllable post-production modifications can be performed. Aptamers have been therapeutically used for age-related macular degeneration, cancer, thrombosis and inflammatory diseases. The aim of this review is to highlight the therapeutic, diagnostic and prognostic possibilities associated with aptamers, focusing on eye pathological angiogenesis.

scholarly journals The role of future treatments in the management of neovascular age-related macular degeneration in Europe

2021 ◽  
pp. 112067212110183
Author(s):  
Laurent Kodjikian ◽  
Carl Joe Mehanna ◽  
Salomon-Yves Cohen ◽  
François Devin ◽  
Sam Razavi ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Macular Degeneration ◽  
Age Related Macular Degeneration ◽  
Phase Iii ◽  
Vascular Endothelial ◽  
Real World Data ◽  
Phase Iii Clinical Trials ◽  
Age Related ◽  
Injection Frequency ◽  
Endothelial Growth Factor

Anti-vascular endothelial growth factor (VEGF) agents have transformed the management of patients with neovascular age-related macular degeneration (nAMD) over the past two decades. However, as more long-term real-world data become available, it is clear that treatment outcomes are inferior to those reported in large, controlled clinical trials. This is largely driven by undertreatment, that is, not maintaining a consistent injection frequency to achieve sustained VEGF suppression, whether due to patient non-compliance, an important injection burden, or non/incomplete anatomical response. Newer therapeutic advances under evaluation hold promise in achieving more, for less. We review the latest drugs currently in or having successfully finished phase III clinical trials, and determine their potential place in the management of patients with nAMD in Europe.

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.

scholarly journals Long-term Use of Aspirin and Age-related Macular Degeneration

2013 ◽  
Vol 06 (02) ◽  
pp. 144 ◽  
Author(s):  
William G Christen ◽  
Emily Y Chew ◽  
◽  
Keyword(s):  
Macular Degeneration ◽  
Observational Studies ◽  
Randomized Trials ◽  
Epidemiologic Studies ◽  
Age Related Macular Degeneration ◽  
Neovascular Amd ◽  
Age Related ◽  
The Us ◽  
Regular Aspirin

Recent findings from observational epidemiologic studies have raised concern about a possible adverse effect of regular aspirin use in age-related macular degeneration (AMD), and in particular neovascular AMD, which is the leading cause of severe irreversible blindness in the US. In this report, we consider these findings in light of the relative strengths and limitations of observational studies and randomized trials. While the findings are important and warrant further investigation, the inherent limitations of observation studies, most notably uncontrolled confounding, preclude an interpretation of causality. Alternatively, the most reliable evidence with which to evaluate the effects of regular aspirin use in AMD will derive from well-designed randomized trials of sufficient size and duration.

scholarly journals Drusen and pigment abnormality predict the development of neovascular age-related macular degeneration in Japanese patients

PLoS ONE ◽  
2021 ◽  
Vol 16 (7) ◽  
pp. e0255213
Author(s):  
Shoji Notomi ◽  
Satomi Shiose ◽  
Keijiro Ishikawa ◽  
Yosuke Fukuda ◽  
Kumiko Kano ◽  
...  
Keyword(s):  
Macular Degeneration ◽  
Japanese Patients ◽  
Age Related Macular Degeneration ◽  
Neovascular Amd ◽  
Fellow Eye ◽  
Factors Associated ◽  
Asian Populations ◽  
Age Related ◽  
The Mean

Drusen are known to be the important hallmark to predict the development of age-related macular degeneration (AMD). The prevalence of drusen is lower in Asians compared with Caucasians so that the role of signs constituting early AMD is not well established in Asian populations as in Western countries. In this study, we retrospectively investigated clinical characteristics and 5-year incidence of neovascular AMD (nAMD) in the fellow eye of unilateral nAMD patients. Of 296 consecutive unilateral nAMD patients who had been followed up more than 5 years, 170 typical AMD, 119 polypoidal choroidal vasculopathy, and 7 retinal angiomatous proliferation were included. To examine factors associated with nAMD occurrence in the fellow eye, drusen and pigmentary abnormality in the fellow eye were classified into 4 categories; Category 1: no or small drusen < 63 μm (37.2%), Category 2: 63–125 μm medium drusen or pigmentary abnormality (22.2%), Category 3: large drusen > 125 μm (25.0%), Category P: pachydrusen (15.5%). The mean sub-foveal choroidal thickness (SFCT) was Category 1: 276 μm, Category 2: 308 μm, Category 3: 246 μm, and Category P: 302 μm, respectively. Of note, SFCT in Category 2 and Category P was significantly larger than those of Category 3. Finally, the 5-year incidence of nAMD in the fellow eye was 32/296 (10.8%); Category 1: 0/110 (0%), Category 2: 12/66 (18.2%), Category 3: 20/74 (27.0%), and Category P: 0/46 (0%). Thus, signs of intermediate AMD (large drusen) as well as those of early AMD, especially the pigmentary abnormality, may contribute to development of bilateral nAMD in Japanese patients.

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