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Article: Systematic Review of Neovascular Age-Related Macular Degeneration Disease Activity Criteria Use to Shorten, Maintain or Extend Treatment Intervals with Anti-VEGF in Clinical Trials: Implications for Clinical Practice.

Patel, Praveen J / Villavicencio, Pablo / Hanumunthadu, Daren

Ophthalmology and therapy

2023 Volume 12, Issue 5, Page(s) 2323–2346

Abstract: Introduction: Clinical trials in neovascular age-related macular degeneration (nAMD) using anti-vascular endothelial growth factor (ant-VEGF) injections use disease activity (DA) criteria to shorten, maintain or increase the interval between injections. ...

Abstract	Introduction: Clinical trials in neovascular age-related macular degeneration (nAMD) using anti-vascular endothelial growth factor (ant-VEGF) injections use disease activity (DA) criteria to shorten, maintain or increase the interval between injections. Differences in these DA criteria may contribute to differences in the proportions of patients with macular fluid at key time points or achieving extended dosing intervals in these trials. We identified, collated and evaluated DA criteria from pivotal anti-VEGF nAMD trials to understand how differences impact on these studies and real-world visual acuity and extending dosing outcomes. Methods: This was a systematic review of literature on Pubmed for randomised clinical trials in nAMD using a proactive treatment regimen. We excluded case reports, review articles and studies on fewer than 50 participants. Results: Twelve clinical trials (LUCAS, VIEW, TREX-AMD, FLUID, TREND, RIVAL, ALTAIR, CANTREAT, ARIES, TREX-Conbercept, HAWK & HARRIER, TENAYA & LUCERNE) investigating anti-VEGF treatment of nAMD were identified according to our search strategy. Different studies utilised a different combination of DA criteria. Specifically, six trials included visual acuity change; four included macular thickness change; one included visual acuity change if associated with macular thickness change; one with qualitative optical coherence tomography (OCT) features; four with qualitative OCT features if also associated with visual acuity change; 10 with macular haemorrhage and five with other fluorescein angiographic features. Conclusion: Different clinical trials use different DA criteria when altering the interval between anti-VEGF injections. This makes it difficult to draw meaningful conclusions about secondary outcomes such as proportion of patients treated at extended dosing intervals or proportions of eyes with persistent subretinal or intraretinal fluid. Standardising DA criteria in clinical trials and preferentially using those easily applied in a real-world setting would lead to results more achievable in real-world settings and for a meaningful comparison of treatment durability.
Language	English
Publishing date	2023-07-21
Publishing country	England
Document type	Journal Article ; Review
ISSN	2193-8245
ISSN	2193-8245
DOI	10.1007/s40123-023-00768-z
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Article: Real-World Outcomes of Anti-VEGF Therapy in Diabetic Macular Oedema: Barriers to Treatment Success and Implications for Low/Lower-Middle-Income Countries.

Sam-Oyerinde, Olapeju A / Patel, Praveen J

Ophthalmology and therapy

2023 Volume 12, Issue 2, Page(s) 809–826

Abstract: Diabetic macular oedema (DMO) is the leading cause of vision loss associated with diabetic eye disease. The exponential increase in the diabetic population and thus, of DMO is an impetus for optimizing the management of DMO. One major challenge in DMO ... ...

Abstract	Diabetic macular oedema (DMO) is the leading cause of vision loss associated with diabetic eye disease. The exponential increase in the diabetic population and thus, of DMO is an impetus for optimizing the management of DMO. One major challenge in DMO management is the discrepancy between treatment outcomes seen in clinical trials and the real world. Contrary to the homogeneity, better patient motivation and shorter study durations seen in randomised control trials, routine clinical practice is fraught with more diverse populations, undertreatment and variable compliance with long-term therapy. Under both circumstances, this review aims to compare efficacy outcomes and adverse events of DMO therapies within the scope of anti-vascular endothelial growth factor (anti-VEGF) medications, specifically the commonly used ones-bevacizumab, ranibizumab and aflibercept. Impediments and methods to achieve better treatment outcomes in the real world will be addressed to achieve better outcomes. Low- to lower-middle-income countries are faced with even more barriers which range from paucity of data on epidemiology and treatment response to scarce human and financial resources to poorer national level attention and then basic issues like transportation. Additionally, to address the lack of a global consensus in DMO treatment, this review generates and recommends, for clinical and research purposes, an up-to-date consensus algorithm for DMO management universally. Underpinned by results from clinical trials and recent guidelines, this therapeutic flowchart can be utilised in various resource settings including low- and lower-middle-income countries where affordability is a major deterrent to treatment access.
Language	English
Publishing date	2023-02-23
Publishing country	England
Document type	Journal Article ; Review
ISSN	2193-8245
ISSN	2193-8245
DOI	10.1007/s40123-023-00672-6
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Article: Comparison of Widefield OCT Angiography Features Between Severe Non-Proliferative and Proliferative Diabetic Retinopathy.

Drira, Ines / Noor, Maha / Stone, Amy / D'Souza, Yvonne / John, Binu / McGrath, Orlaith / Patel, Praveen J / Aslam, Tariq

Ophthalmology and therapy

2024 Volume 13, Issue 3, Page(s) 831–849

Abstract: Introduction: There is a high and ever-increasing global prevalence of diabetic retinopathy (DR) and invasive imaging techniques are often required to confirm the presence of proliferative disease. The aim of this study was to explore the images of a ... ...

Abstract	Introduction: There is a high and ever-increasing global prevalence of diabetic retinopathy (DR) and invasive imaging techniques are often required to confirm the presence of proliferative disease. The aim of this study was to explore the images of a rapid and non-invasive technique, widefield optical coherence tomography angiography (OCT-A), to study differences between patients with severe non-proliferative and proliferative DR (PDR). Methods: We conducted an observational longitudinal study from November 2022 to March 2023. We recruited 75 patients who were classified into a proliferative group (28 patients) and severe non-proliferative group (47 patients). Classification was done by specialist clinicians who had full access to any multimodal imaging they required to be confident of their diagnosis, including fluorescein angiography. For all patients, we performed single-shot 4 × 4 and 10 × 10 mm (widefield) OCT-A imaging and when possible, the multiple images required for mosaic 17.5 × 17.5 mm (ultra widefield) OCT-A imaging. We assessed the frequency with which proliferative disease was identifiable solely from these OCT-A images and used custom-built MATLAB software to analyze the images and determine computerized metrics such as density and intensity of vessels, foveal avascular zone, and ischemic areas. Results: On clinically assessing the OCT-A 10 × 10 fields, we were only able to detect new vessels in 25% of known proliferative images. Using ultra-widefield mosaic images, however, we were able to detect new vessels in 100% of PDR patients. The image analysis metrics of 4 × 4 and 10 × 10 mm images did not show any significant differences between the two clinical groups. For mosaics, however, there were significant differences in the capillary density in patients with PDR compared to severe non-PDR (9.1% ± 1.9 in the PDR group versus 11.0% ± 1.9 for severe group). We also found with mosaics a significant difference in the metrics of ischemic areas; average area of ischemic zones (253,930.1 ± 108,636 for the proliferative group versus 149,104.2 ± 55,101.8 for the severe group. Conclusions: Our study showed a high sensitivity for detecting PDR using only ultra-widefield mosaic OCT-A imaging, compared to multimodal including fluorescein angiography imaging. It also suggests that image analysis of aspects such as ischemia levels may be useful in identifying higher risk groups as a warning sign for future conversion to neovascularization.
Language	English
Publishing date	2024-01-25
Publishing country	England
Document type	Journal Article
ISSN	2193-8245
ISSN	2193-8245
DOI	10.1007/s40123-024-00886-2
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Article ; Online: Rare complement factor I variants associated with reduced macular thickness and age-related macular degeneration in the UK Biobank.

Tzoumas, Nikolaos / Kavanagh, David / Cordell, Heather J / Lotery, Andrew J / Patel, Praveen J / Steel, David H

Human molecular genetics

2022 Volume 31, Issue 16, Page(s) 2678–2692

Abstract: To evaluate potential diagnostic and therapeutic biomarkers for age-related macular degeneration (AMD), we identified 8433 UK Biobank participants with rare complement Factor I gene (CFI) variants, 579 with optical coherence tomography-derived macular ... ...

Abstract	To evaluate potential diagnostic and therapeutic biomarkers for age-related macular degeneration (AMD), we identified 8433 UK Biobank participants with rare complement Factor I gene (CFI) variants, 579 with optical coherence tomography-derived macular thickness data. We stratified these variants by predicted gene expression and measured their association with retinal pigment epithelium-Bruch's membrane (RPE-BM) complex and retinal thicknesses at nine macular subfields, as well as AMD risk, using multivariable regression models adjusted for the common complement Factor H gene (CFH) p.Y402H and age-related maculopathy susceptibility protein 2 gene (ARMS2) p.A69S risk genotypes. CFI variants associated with low Factor I levels predicted a thinner mean RPE-BM (95% confidence interval [CI] -1.66 to -0.37 μm, P = 0.002) and retina (95% CI -5.88 to -0.13 μm, P = 0.04) and a higher AMD risk (odds ratio [OR] = 2.26, 95% CI 1.56 to 3.27, P < 0.001). CFI variants associated with normal Factor I levels did not impact mean RPE-BM/retinal thickness (P = 0.28; P = 0.99) or AMD risk (P = 0.97). CFH p.Y402H was associated with a thinner RPE-BM (95% CI -0.31 to -0.18 μm, P < 0.001 heterozygous; 95% CI -0.62 to -0.42 μm, P < 0.001 homozygous) and retina (95% CI -0.73 to -0.12 μm, P = 0.007 heterozygous; 95% CI -1.08 to -0.21 μm, P = 0.004 homozygous). ARMS2 p.A69S did not influence RPE-BM (P = 0.80 heterozygous; P = 0.12 homozygous) or retinal thickness (P = 0.75 heterozygous; P = 0.07 homozygous). p.Y402H and p.A69S exhibited a significant allele-dose response with AMD risk. Thus, CFI rare variants associated with low Factor I levels are robust predictors of reduced macular thickness and AMD. The observed association between macular thickness and CFH p.Y402H, but not ARMS2 p.A69S, highlights the importance of complement dysregulation in early pathogenesis.
MeSH term(s)	Biological Specimen Banks ; Complement Factor H/genetics ; Complement Factor I/genetics ; Fibrinogen/genetics ; Genotype ; Humans ; Macular Degeneration/genetics ; Polymorphism, Single Nucleotide/genetics ; United Kingdom
Chemical Substances	Complement Factor H (80295-65-4) ; Fibrinogen (9001-32-5) ; Complement Factor I (EC 3.4.21.45)
Language	English
Publishing date	2022-03-11
Publishing country	England
Document type	Journal Article
ZDB-ID	1108742-0
ISSN	1460-2083 ; 0964-6906
ISSN (online)	1460-2083
ISSN	0964-6906
DOI	10.1093/hmg/ddac060
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Article ; Online: Is preventable sight loss truly preventable? An exploration of a public health indicator for sight loss due to age-related macular degeneration in England.

Brown, Kelsey / Bunce, Catey / Onabanjo, Oluwaseun / Strong, Stacey A / Patel, Praveen J

Eye (London, England)

2022 Volume 37, Issue 3, Page(s) 516–523

Abstract: Background: Age-related macular degeneration accounts for the majority of severe sight impairment and sight impairment registration and certifications in adults in the UK [1, 2]. Whilst these treatments are effective in arresting nAMD progression, there ...

Abstract	Background: Age-related macular degeneration accounts for the majority of severe sight impairment and sight impairment registration and certifications in adults in the UK [1, 2]. Whilst these treatments are effective in arresting nAMD progression, there is currently no treatment for GA [1, 3, 4]. Methods: This paper provides an update to the data collected by Bunce et al. [3] and details the number of people certified together with incidence rates for the various types of AMD by: sex, sight impairment status, and for all ages using the 2016/2017 and 2017/2018 CVI due to AMD data for England from the Moorfields Eye Hospital, supplemented with 2017-2018 PHOF indicator 4.12i/E12a data. The study population includes individuals of all ages in England who were newly certified with visual impairment due to AMD. Results: Between 2016 and 2017, CVIs due to AMD totalled to 11,215; between 2017 and 2018, CVIs due to AMD totalled to 10,914. The PHOF indicator 4.12i/E12a assessed showed that overall rates of AMD certifications have steadily declined in England from 131.5 per 100,000 in 2010/2011 to 106.7 per 100,000 in 2017/2018. Conclusion: As treatment is available for nAMD, a reduction in nAMD certifications could be expected; however, growth of the elderly population in England combined with there currently being no treatment available for GA means AMD certification rates should be increasing. Therefore, it is postulated that not all cases of AMD are being certified and registered with some likely going undiagnosed.
MeSH term(s)	Adult ; Humans ; Aged ; Public Health ; Registries ; England/epidemiology ; Macular Degeneration/epidemiology ; Vision Disorders/epidemiology ; Blindness
Language	English
Publishing date	2022-02-23
Publishing country	England
Document type	Journal Article ; Comment
ZDB-ID	91001-6
ISSN	1476-5454 ; 0950-222X
ISSN (online)	1476-5454
ISSN	0950-222X
DOI	10.1038/s41433-022-01933-7
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Article: A Systematic Review of the Treat and Extend Treatment Regimen with Anti-VEGF Agents for Neovascular Age-Related Macular Degeneration.

Gemenetzi, Maria / Patel, Praveen J

Ophthalmology and therapy

2017 Volume 6, Issue 1, Page(s) 79–92

Abstract: Despite significant progress in retaining vision for neovascular age-related macular degeneration patients in the era of treatment with intravitreal anti-VEGF agents, there is no universally accepted treatment regimen that defines the frequency of ... ...

Abstract	Despite significant progress in retaining vision for neovascular age-related macular degeneration patients in the era of treatment with intravitreal anti-VEGF agents, there is no universally accepted treatment regimen that defines the frequency of treatment needed to achieve the optimal visual outcomes while simultaneously balancing the burden of long-term, frequent and high-cost treatment. Treat and extend has recently and consistently been used by retina specialists to minimise the financial and psychological costs of the need for frequent treatment with anti-VEGF injections. This is a systematic review that presents evidence from clinical trials and the real world on the utilisation of treat and extend with anti-VEGF intravitreal injections in neovascular age-related macular degeneration, and discusses the experience gained thus far from the utilisation of such regimens to preserve vision when treating patients over the long-term.
Language	English
Publishing date	2017-04-27
Publishing country	England
Document type	Journal Article ; Review
ISSN	2193-8245
ISSN	2193-8245
DOI	10.1007/s40123-017-0087-5
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Article ; Online: Sub-cellular level resolution of common genetic variation in the photoreceptor layer identifies continuum between rare disease and common variation.

Currant, Hannah / Fitzgerald, Tomas W / Patel, Praveen J / Khawaja, Anthony P / Webster, Andrew R / Mahroo, Omar A / Birney, Ewan

PLoS genetics

2023 Volume 19, Issue 2, Page(s) e1010587

Abstract: Photoreceptor cells (PRCs) are the light-detecting cells of the retina. Such cells can be non-invasively imaged using optical coherence tomography (OCT) which is used in clinical settings to diagnose and monitor ocular diseases. Here we present the ... ...

Abstract	Photoreceptor cells (PRCs) are the light-detecting cells of the retina. Such cells can be non-invasively imaged using optical coherence tomography (OCT) which is used in clinical settings to diagnose and monitor ocular diseases. Here we present the largest genome-wide association study of PRC morphology to date utilising quantitative phenotypes extracted from OCT images within the UK Biobank. We discovered 111 loci associated with the thickness of one or more of the PRC layers, many of which had prior associations to ocular phenotypes and pathologies, and 27 with no prior associations. We further identified 10 genes associated with PRC thickness through gene burden testing using exome data. In both cases there was a significant enrichment for genes involved in rare eye pathologies, in particular retinitis pigmentosa. There was evidence for an interaction effect between common genetic variants, VSX2 involved in eye development and PRPH2 known to be involved in retinal dystrophies. We further identified a number of genetic variants with a differential effect across the macular spatial field. Our results suggest a continuum between common and rare variation which impacts retinal structure, sometimes leading to disease.
MeSH term(s)	Humans ; Rare Diseases/pathology ; Genome-Wide Association Study ; Retina/pathology ; Photoreceptor Cells ; Genetic Variation
Language	English
Publishing date	2023-02-27
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2186725-2
ISSN	1553-7404 ; 1553-7390
ISSN (online)	1553-7404
ISSN	1553-7390
DOI	10.1371/journal.pgen.1010587
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Article ; Online: Biomarkers of macular neovascularisation activity using optical coherence tomography angiography in treated stable neovascular age related macular degeneration.

Hanumunthadu, Daren / Saleh, Azahir / Florea, Daniela / Balaskas, Konstantinos / Keane, Pearse A / Aslam, Tariq / Patel, Praveen J

BMC ophthalmology

2023 Volume 23, Issue 1, Page(s) 68

Abstract: Background: The aim of this study was to describe features of disease activity in patients with treated stable macular neovascularisation (MNV) in neovascular age related macular degeneration (nAMD) using optical coherence tomography angiography (OCTA).! ...

Abstract	Background: The aim of this study was to describe features of disease activity in patients with treated stable macular neovascularisation (MNV) in neovascular age related macular degeneration (nAMD) using optical coherence tomography angiography (OCTA). Methods: Thirty-two eyes of 32 patients with nAMD were included in this prospective, observational study. These patients were undergoing treatment with aflibercept on a treat-and-extend regimen attending an extension to a 12-week treatment interval. Results: All subjects had no macular haemorrhage and no structural OCT markers of active MNV activity at the index 12-week treatment extension visit. 31/32 OCTA images were gradeable without significant imaging artefact. The mean MNV size was 3.6mm Conclusions: MNV blood flow is still detectable using OCTA in the majority of subjects in this study with treated stable MNV. OCTA features associated included MNV mature phenotype, MNV feeder vessel, MNV halo and absence of capillary fringe.
MeSH term(s)	Humans ; Tomography, Optical Coherence/methods ; Fluorescein Angiography/methods ; Prospective Studies ; Choroidal Neovascularization/diagnosis ; Choroidal Neovascularization/drug therapy ; Macular Degeneration/diagnosis ; Macular Degeneration/drug therapy ; Biomarkers ; Wet Macular Degeneration/diagnosis ; Wet Macular Degeneration/drug therapy ; Angiogenesis Inhibitors/therapeutic use
Chemical Substances	Biomarkers ; Angiogenesis Inhibitors
Language	English
Publishing date	2023-02-14
Publishing country	England
Document type	Observational Study ; Journal Article
ZDB-ID	2050436-6
ISSN	1471-2415 ; 1471-2415
ISSN (online)	1471-2415
ISSN	1471-2415
DOI	10.1186/s12886-022-02749-5
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Article ; Online: Inclusive research in ophthalmology is mission critical! The 10-point action plan.

Dinah, Christiana / Williams, Olayinka / Varma, Deepali / Reynolds, Rhianon / Patel, Praveen J / Mulholland, Padraig / Ghanchi, Faruque / Bourne, Rupert R A

Eye (London, England)

2023 Volume 38, Issue 2, Page(s) 235–237

MeSH term(s)	Humans ; Ophthalmology/trends ; Biomedical Research/trends
Language	English
Publishing date	2023-07-24
Publishing country	England
Document type	Journal Article
ZDB-ID	91001-6
ISSN	1476-5454 ; 0950-222X
ISSN (online)	1476-5454
ISSN	0950-222X
DOI	10.1038/s41433-023-02677-8
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Article ; Online: Deep-learning automated quantification of longitudinal OCT scans demonstrates reduced RPE loss rate, preservation of intact macular area and predictive value of isolated photoreceptor degeneration in geographic atrophy patients receiving C3 inhibition treatment.

Fu, Dun Jack / Glinton, Sophie / Lipkova, Veronika / Faes, Livia / Liefers, Bart / Zhang, Gongyu / Pontikos, Nikolas / McKeown, Alex / Scheibler, Lukas / Patel, Praveen J / Keane, Pearse A / Balaskas, Konstantinos

The British journal of ophthalmology

2024 Volume 108, Issue 4, Page(s) 536–545

Abstract: Objective: To evaluate the role of automated optical coherence tomography (OCT) segmentation, using a validated deep-learning model, for assessing the effect of C3 inhibition on the area of geographic atrophy (GA); the constituent features of GA on OCT ( ...

Abstract	Objective: To evaluate the role of automated optical coherence tomography (OCT) segmentation, using a validated deep-learning model, for assessing the effect of C3 inhibition on the area of geographic atrophy (GA); the constituent features of GA on OCT (photoreceptor degeneration (PRD), retinal pigment epithelium (RPE) loss and hypertransmission); and the area of unaffected healthy macula.To identify OCT predictive biomarkers for GA growth. Methods: Post hoc analysis of the FILLY trial using a deep-learning model for spectral domain OCT (SD-OCT) autosegmentation. 246 patients were randomised 1:1:1 into pegcetacoplan monthly (PM), pegcetacoplan every other month (PEOM) and sham treatment (pooled) for 12 months of treatment and 6 months of therapy-free monitoring. Only participants with Heidelberg SD-OCT were included (n=197, single eye per participant).The primary efficacy endpoint was the square root transformed change in area of GA as complete RPE and outer retinal atrophy (cRORA) in each treatment arm at 12 months, with secondary endpoints including RPE loss, hypertransmission, PRD and intact macular area. Results: Eyes treated PM showed significantly slower mean change of cRORA progression at 12 and 18 months (0.151 and 0.277 mm, p=0.0039; 0.251 and 0.396 mm, p=0.039, respectively) and RPE loss (0.147 and 0.287 mm, p=0.0008; 0.242 and 0.410 mm, p=0.00809). PEOM showed significantly slower mean change of RPE loss compared with sham at 12 months (p=0.0313). Intact macular areas were preserved in PM compared with sham at 12 and 18 months (p=0.0095 and p=0.044). PRD in isolation and intact macula areas was predictive of reduced cRORA growth at 12 months (coefficient 0.0195, p=0.01 and 0.00752, p=0.02, respectively) CONCLUSION: The OCT evidence suggests that pegcetacoplan slows progression of cRORA overall and RPE loss specifically while protecting the remaining photoreceptors and slowing the progression of healthy retina to iRORA.
MeSH term(s)	Humans ; Atrophy ; Deep Learning ; Fluorescein Angiography/methods ; Geographic Atrophy/diagnosis ; Geographic Atrophy/drug therapy ; Geographic Atrophy/pathology ; Retina ; Retinal Pigment Epithelium/pathology ; Tomography, Optical Coherence/methods
Language	English
Publishing date	2024-03-20
Publishing country	England
Document type	Randomized Controlled Trial ; Journal Article
ZDB-ID	80078-8
ISSN	1468-2079 ; 0007-1161
ISSN (online)	1468-2079
ISSN	0007-1161
DOI	10.1136/bjo-2022-322672
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