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Article ; Online: Comparison of intravitreal injections of Ranibizumab and Aflibercept in neovascular age related macular degeneration.

Sizmaz, Selcuk / Esen, Ebru / Isik-Ericek, Puren / Demircan, Nihal

2021 Volume 105, Issue 1, Page(s) 55–60

Abstract: ... Clinical ... ...

Abstract	Clinical relevance
MeSH term(s)	Aged ; Aged, 80 and over ; Angiogenesis Inhibitors ; Follow-Up Studies ; Humans ; Intravitreal Injections ; Macular Degeneration/diagnosis ; Macular Degeneration/drug therapy ; Middle Aged ; Ranibizumab ; Receptors, Vascular Endothelial Growth Factor ; Recombinant Fusion Proteins ; Retrospective Studies ; Tomography, Optical Coherence/methods ; Treatment Outcome ; Vascular Endothelial Growth Factor A
Chemical Substances	Angiogenesis Inhibitors ; Recombinant Fusion Proteins ; Vascular Endothelial Growth Factor A ; aflibercept (15C2VL427D) ; Receptors, Vascular Endothelial Growth Factor (EC 2.7.10.1) ; Ranibizumab (ZL1R02VT79)
Language	English
Publishing date	2021-03-15
Publishing country	United States
Document type	Comparative Study ; Journal Article
ZDB-ID	639275-1
ISSN	1444-0938 ; 0816-4622
ISSN (online)	1444-0938
ISSN	0816-4622
DOI	10.1080/08164622.2021.1896334
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Article: The role of mitochondrial genes on nuclear gene expression in neovascular age related macular degeneration: analysis of nuclear VEGF gene expression after ranibizumab treatment in cytoplasmic hybrid retinal pigment epithelial cell lines correlated with clinical evolution.

Costa, Rodrigo Donato / Thomaz Neto, Farid José / Moustafa, M Tarek / Atilano, Shari R / Chwa, Marilyn / Cáceres-Del-Carpi, Javier / Mohamed, Mohamed Hamid / Kenney, M Cristina / Kuppermann, Baruch D

International journal of retina and vitreous

2023 Volume 9, Issue 1, Page(s) 44

Abstract: ... age-related macular degeneration (AMD) therapies.: Methods: Mitochondria deficient ARPE-19 cells (Rho0) were fused with AMD ... and 10X (P = < 0.0001). Clinically, Patient-02 presented with a neovascular lesion associated ... the potential to help personalize the treatment regimen with anti-VEGF drugs in patients with neovascular AMD ...

Abstract	Purpose: The present study tests the hypothesis that mitochondrial genes have retrograde signaling capacity that influences the expression of nuclear genes related to angiogenesis pathways. Cytoplasmic hybrid (cybrid) in vitro cell lines with patient specific mitochondria inserted into an immortalized retinal pigment epithelial cell line (ARPE-19) were used to test this hypothesis. This type of analysis can provide important information to identify the optimal regimen of anti-VEGF treatment, personalizing age-related macular degeneration (AMD) therapies. Methods: Mitochondria deficient ARPE-19 cells (Rho0) were fused with AMD donor's platelets to create individual cybrid cell lines containing mitochondria from patients with phenotypic AMD disease and nuclear DNA from the immortalized RPE cell line. The cybrids were treated with Ranibizumab (Lucentis, Genentech, San Francisco, CA), at 4 different concentrations for 24 h, and subsequently the levels of reactive oxygen species (ROS), gene expression for VEGF-A, hypoxia-inducible factor 1-alpha (HIF1-a) and manganese superoxide dismutase (SOD2) were measured. The clinical evolution of the two AMD-donors were correlated with the molecular findings found in their 'personalized' cybrids. Results: Cybrids from Patient-01 showed down-regulation of gene expression of VEGF-A and HIF-1a at both 1X and 4X Ranibizumab concentrations. Patient-01 AMD cybrid cultures had an increase in the ROS levels at 1X (P = 0.0317), no changes at 2X (P = 0.8350) and a decrease at 4X (P = 0.0015) and 10X (P = 0.0011) of Ranibizumab. Clinically, Patient-01 responded to anti-VEGF therapy but eventually developed geographic atrophy. Patient-02 cybrids demonstrated up-regulation of gene expression of VEGF-A and HIF-1a at Ranibizumab 1X and 4X concentrations. There was decreased ROS levels with Ranibizumab 1X (P = 0.1606), 2X (P = 0.0388), 4X (P = 0.0010) and 10X (P = < 0.0001). Clinically, Patient-02 presented with a neovascular lesion associated with a prominent production of intraretinal fluid in clinical follow-up requiring regular and repeated intravitreal injections of Ranibizumab with recurrent subretinal fluid. Conclusions: Our cybrid model has the potential to help personalize the treatment regimen with anti-VEGF drugs in patients with neovascular AMD. Further investigation is needed to better understand the role that the mitochondria play in the cellular response to anti-VEGF drugs. Future studies that focus on this model have the potential to help personalize anti-VEGF treatment.
Language	English
Publishing date	2023-07-25
Publishing country	England
Document type	Journal Article
ZDB-ID	2836254-8
ISSN	2056-9920
ISSN	2056-9920
DOI	10.1186/s40942-023-00476-7
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Article ; Online: Caregiver Burden in Patients Receiving Ranibizumab Therapy for Neovascular Age Related Macular Degeneration.

Gohil, Rishma / Crosby-Nwaobi, Roxanne / Forbes, Angus / Burton, Ben / Hykin, Phil / Sivaprasad, Sobha

PloS one

2015 Volume 10, Issue 6, Page(s) e0129361

Abstract: ... ranibizumab therapy for neovascular AMD (nAMD).: Methods: This is a cross-sectional questionnaire survey ... vision related quality of life, demographics, satisfaction and support provided by the healthcare and ... respectively.: Conclusion: Ranibizumab therapy for nAMD is associated with significant caregiver burden ...

Abstract	Purpose: To assess the caregiver burden and factors determining the burden in patients receiving ranibizumab therapy for neovascular AMD (nAMD). Methods: This is a cross-sectional questionnaire survey of 250 matched patient caregiver dyads across three large ophthalmic treatment centres in United Kingdom. The primary outcome was the subjective caregiver burden measured using caregiver reaction assessment scale (CRA). Objective caregiver burden was determined by the caregiver tasks and level of care provided. The factors that may predict the caregiver burden such as the patient's visual acuity of the better eye and vision related quality of life, demographics, satisfaction and support provided by the healthcare and the health status of the dyads were also collected and assessed in a hierarchical regression model. Results: The mean CRA score was 3.2±0.5, similar to the score reported by caregivers for atrial fibrillation who require regular hospital appointments for monitoring their thromboprophylaxis. Caregiver tasks including accompanying for hospital appointments for eye treatment and patient's visual acuity in the better eye were the biggest contributors to the caregiver burden hierarchical model explaining 18% and 11% of the variance respectively. Conclusion: Ranibizumab therapy for nAMD is associated with significant caregiver burden. Both disease impact and treatment frequency contributed to the overall burden.
MeSH term(s)	Aged ; Aged, 80 and over ; Caregivers/psychology ; Cost of Illness ; Cross-Sectional Studies ; Female ; Health Status ; Humans ; Macular Degeneration/drug therapy ; Male ; Middle Aged ; Personal Satisfaction ; Quality of Life ; Ranibizumab/therapeutic use ; Surveys and Questionnaires ; United Kingdom ; Visual Acuity/physiology
Chemical Substances	Ranibizumab (ZL1R02VT79)
Language	English
Publishing date	2015
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ISSN	1932-6203
ISSN (online)	1932-6203
DOI	10.1371/journal.pone.0129361
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Article: Evaluation of the effect of intravitreal ranibizumab injections in patients with neovascular age related macular degeneration on retinal nerve fiber layer thickness using optical coherence tomography.

El-Ashry, Mohamed F / Lascaratos, Gerassimos / Dhillon, Baljean

Clinical ophthalmology (Auckland, N.Z.)

2015 Volume 9, Page(s) 1269–1274

Abstract: ... age related macular degeneration (nAMD) on the retinal nerve fiber layer (RNFL) thickness using optical coherence tomography ... Purpose: To evaluate the effect of repeated intravitreal ranibizumab injections for neovascular ... as well as the type of choroidal neovascular membrane on RNFL thickness measurements pre- and post ...

Abstract	Purpose: To evaluate the effect of repeated intravitreal ranibizumab injections for neovascular age related macular degeneration (nAMD) on the retinal nerve fiber layer (RNFL) thickness using optical coherence tomography. Design: A prospective observational cohort study of patients with nAMD. Methods: Thirty eyes of 30 patients with nAMD were selected. All patients received three ranibizumab injections and underwent scans using the fast RNFL thickness protocol (Stratus optical coherence tomography) before starting the first injection and 1 month after the third injection. The RNFL thickness measurements prior to the injections and after the third injection were used for the analysis. We also evaluated the effect of the lens status as well as the type of choroidal neovascular membrane on RNFL thickness measurements pre- and post-injection. Pre- and post-injection average and individual quadrant RNFL thickness were measured and statistically analyzed. Results: The mean (± standard deviation) pre-injection RNFL thickness was 90.8±18. The mean (± standard deviation) post-injection RNFL thickness was 91.03±15. The pre- and post-injection values of the mean RNFL thickness were not statistically significant. Likewise, the pre- and post-injection values for RNFL thickness in the different quadrants were not statistically significant. There was no statistical significance for the lens status or the type of choroidal neovascular membrane on the RNFL thickness. Conclusion: Repeated ranibizumab injections in nAMD appear to have no harmful effect on the RNFL thickness in the short term, in spite of the proven neurotrophic effect of vascular endothelial growth factor. Nevertheless, the safety profile of ranibizumab injections in nAMD needs to be further evaluated in a large multicenter trial with special emphasis on the long-term effects on the retina and optic nerve.
Language	English
Publishing date	2015-07-13
Publishing country	New Zealand
Document type	Journal Article
ISSN	1177-5467
ISSN	1177-5467
DOI	10.2147/OPTH.S80704
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Article ; Online: Caregiver Burden in Patients Receiving Ranibizumab Therapy for Neovascular Age Related Macular Degeneration.

Rishma Gohil / Roxanne Crosby-Nwaobi / Angus Forbes / Ben Burton / Phil Hykin / Sobha Sivaprasad

PLoS ONE, Vol 10, Iss 6, p e

2015 Volume 0129361

Abstract: ... therapy for neovascular AMD (nAMD).This is a cross-sectional questionnaire survey of 250 matched patient ... To assess the caregiver burden and factors determining the burden in patients receiving ranibizumab ... the caregiver burden such as the patient's visual acuity of the better eye and vision related quality of life ...

Abstract	To assess the caregiver burden and factors determining the burden in patients receiving ranibizumab therapy for neovascular AMD (nAMD).This is a cross-sectional questionnaire survey of 250 matched patient caregiver dyads across three large ophthalmic treatment centres in United Kingdom. The primary outcome was the subjective caregiver burden measured using caregiver reaction assessment scale (CRA). Objective caregiver burden was determined by the caregiver tasks and level of care provided. The factors that may predict the caregiver burden such as the patient's visual acuity of the better eye and vision related quality of life, demographics, satisfaction and support provided by the healthcare and the health status of the dyads were also collected and assessed in a hierarchical regression model.The mean CRA score was 3.2±0.5, similar to the score reported by caregivers for atrial fibrillation who require regular hospital appointments for monitoring their thromboprophylaxis. Caregiver tasks including accompanying for hospital appointments for eye treatment and patient's visual acuity in the better eye were the biggest contributors to the caregiver burden hierarchical model explaining 18% and 11% of the variance respectively.Ranibizumab therapy for nAMD is associated with significant caregiver burden. Both disease impact and treatment frequency contributed to the overall burden.
Keywords	Medicine ; R ; Science ; Q
Subject code	616
Language	English
Publishing date	2015-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Visual outcome of ranibizumab therapy for neovascular age related macular degeneration in the black population: a report of five cases.

Vemala, Roopa / Gupta, Bhaskar / Sivaprasad, Sobha

Clinical ophthalmology (Auckland, N.Z.)

2010 Volume 4, Page(s) 913–916

Abstract: Introduction: Neovascular age related macular degeneration (AMD) is relatively uncommon ... with choroidal neovascular membrane (CNV) secondary to AMD.: Material and methods: Retrospective analysis of a prospective ... in the black population. We report the 12-month outcome of ranibizumab therapy in five black patients ...

Abstract	Introduction: Neovascular age related macular degeneration (AMD) is relatively uncommon in the black population. We report the 12-month outcome of ranibizumab therapy in five black patients with choroidal neovascular membrane (CNV) secondary to AMD. Material and methods: Retrospective analysis of a prospective audit database maintained for all patients on ranibizumab therapy in a retinal specialist unit that caters to a multi-ethnic cohort in London, United Kingdom. Results: At 12 months, all the 5 patients maintained stable vision (loss of less than 15 ETDRS letters). However, none of them gained more than 15 ETDRS letters. All eyes showed early subretinal fibrosis while 2 patients showed extended areas of retinal pigment atrophy. Conclusion: Our case studies indicate that ranibizumab stabilizes the vision in black patients with CNV secondary to AMD but they tend to develop early subretinal fibrosis and retinal pigment atrophy.
Language	English
Publishing date	2010-08-19
Publishing country	New Zealand
Document type	Journal Article
ZDB-ID	2415713-2
ISSN	1177-5483 ; 1177-5483
ISSN (online)	1177-5483
ISSN	1177-5483
DOI	10.2147/opth.s10259
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Article ; Online: Evaluation of the effect of intravitreal ranibizumab injections in patients with neovascular age related macular degeneration on retinal nerve fiber layer thickness using optical coherence tomography

El-Ashry MF / Lascaratos G / Dhillon B

Clinical Ophthalmology, Vol 2015, Iss default, Pp 1269-

2015 Volume 1274

Abstract: ... for neovascular age related macular degeneration (nAMD) on the retinal nerve fiber layer (RNFL) thickness using ... as well as the type of choroidal neovascular membrane on RNFL thickness measurements pre- and post ... significance for the lens status or the type of choroidal neovascular membrane on the RNFL thickness.Conclusion ...

Abstract	Mohamed F El-Ashry,1–3 Gerassimos Lascaratos,1 Baljean Dhillon1,4 1Princess Alexandra Eye Pavilion, Edinburgh, UK; 2Ophthalmology Department, Tanta University Hospital, Tanta, Egypt; 3North Cumbria University Hospital, Carlisle, UK; 4Centre for Clinical Brain Sciences, School of Clinical Sciences, University of Edinburgh, Edinburgh, UK Purpose: To evaluate the effect of repeated intravitreal ranibizumab injections for neovascular age related macular degeneration (nAMD) on the retinal nerve fiber layer (RNFL) thickness using optical coherence tomography.Design: A prospective observational cohort study of patients with nAMD.Methods: Thirty eyes of 30 patients with nAMD were selected. All patients received three ranibizumab injections and underwent scans using the fast RNFL thickness protocol (Stratus optical coherence tomography) before starting the first injection and 1 month after the third injection. The RNFL thickness measurements prior to the injections and after the third injection were used for the analysis. We also evaluated the effect of the lens status as well as the type of choroidal neovascular membrane on RNFL thickness measurements pre- and post-injection. Pre- and post-injection average and individual quadrant RNFL thickness were measured and statistically analyzed.Results: The mean (± standard deviation) pre-injection RNFL thickness was 90.8±18. The mean (± standard deviation) post-injection RNFL thickness was 91.03±15. The pre- and post-injection values of the mean RNFL thickness were not statistically significant. Likewise, the pre- and post-injection values for RNFL thickness in the different quadrants were not statistically significant. There was no statistical significance for the lens status or the type of choroidal neovascular membrane on the RNFL thickness.Conclusion: Repeated ranibizumab injections in nAMD appear to have no harmful effect on the RNFL thickness in the short term, in spite of the proven neurotrophic effect of vascular endothelial growth factor. Nevertheless, the safety profile of ranibizumab injections in nAMD needs to be further evaluated in a large multicenter trial with special emphasis on the long-term effects on the retina and optic nerve. Keywords: optical coherence tomography, anti-VEGF, intraocular pressure, ranibizumab, retinal nerve fiber layer
Keywords	Ophthalmology ; RE1-994 ; Medicine ; R
Language	English
Publishing date	2015-07-01T00:00:00Z
Publisher	Dove Medical Press
Document type	Article ; Online
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Article: Ranibizumab.

Blick, Stephanie K A / Keating, Gillian M / Wagstaff, Antona J

Drugs

2007 Volume 67, Issue 8, Page(s) 1199–206; discussion 1207–9

Abstract: ... III trials in patients with neovascular (wet) age-related macular degeneration (AMD) indicated ... Ranibizumab is the antigen-binding fragment of a recombinant, humanised monoclonal antibody ... that monthly intravitreal injections of ranibizumab 0.3 or 0.5 mg for up to 2 years maintained or improved ...

Abstract	Ranibizumab is the antigen-binding fragment of a recombinant, humanised monoclonal antibody, which binds with high affinity to, and inhibits the activity of, all active forms of vascular endothelial growth factor A, an important mediator in the development of choroidal neovascularisation. Well designed, phase III trials in patients with neovascular (wet) age-related macular degeneration (AMD) indicated that monthly intravitreal injections of ranibizumab 0.3 or 0.5 mg for up to 2 years maintained or improved visual acuity to a greater extent than sham injection, verteporfin photodynamic therapy or sham photodynamic therapy. In patients with predominantly classic wet AMD who received ranibizumab in combination with verteporfin therapy, preliminary results indicate that combination therapy is superior to that of verteporfin therapy alone. Most serious ocular adverse events, which were uncommon, were associated with either the injection procedure or ranibizumab.
MeSH term(s)	Antibodies, Monoclonal/pharmacokinetics ; Antibodies, Monoclonal/pharmacology ; Antibodies, Monoclonal/therapeutic use ; Antibodies, Monoclonal, Humanized ; Clinical Trials, Phase III as Topic ; Humans ; Macular Degeneration/drug therapy ; Ranibizumab
Chemical Substances	Antibodies, Monoclonal ; Antibodies, Monoclonal, Humanized ; Ranibizumab (ZL1R02VT79)
Language	English
Publishing date	2007-05-15
Publishing country	New Zealand
Document type	Journal Article ; Review
ZDB-ID	120316-2
ISSN	1179-1950 ; 0012-6667
ISSN (online)	1179-1950
ISSN	0012-6667
DOI	10.2165/00003495-200767080-00007
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Article ; Online: Machine Learning to Predict Response to Ranibizumab in Neovascular Age-Related Macular Degeneration.

Maunz, Andreas / Barras, Laura / Kawczynski, Michael G / Dai, Jian / Lee, Aaron Y / Spaide, Richard F / Sahni, Jayashree / Ferrara, Daniela

Ophthalmology science

2023 Volume 3, Issue 4, Page(s) 100319

Abstract: Purpose: Neovascular age-related macular degeneration (nAMD) shows variable treatment response ... choroidal neovascularization secondary to age-related macular dengeration.: Methods: Baseline data from 502 study eyes ... were systematically compared with a benchmark linear model of baseline age and BCVA. Quantitative OCT ...

Abstract	Purpose: Neovascular age-related macular degeneration (nAMD) shows variable treatment response to intravitreal anti-VEGF. This analysis compared the potential of different artificial intelligence (AI)-based machine learning models using OCT and clinical variables to accurately predict at baseline the best-corrected visual acuity (BCVA) at 9 months in response to ranibizumab in patients with nAMD. Design: Retrospective analysis. Participants: Baseline and imaging data from patients with subfoveal choroidal neovascularization secondary to age-related macular dengeration. Methods: Baseline data from 502 study eyes from the HARBOR (NCT00891735) prospective clinical trial (monthly ranibizumab 0.5 and 2.0 mg arms) were pooled; 432 baseline OCT volume scans were included in the analysis. Seven models, based on baseline quantitative OCT features (Least absolute shrinkage and selection operator [Lasso] OCT minimum [min], Lasso OCT 1 standard error [SE]); on quantitative OCT features and clinical variables at baseline (Lasso min, Lasso 1SE, CatBoost, RF [random forest]); or on baseline OCT images only (deep learning [DL] model), were systematically compared with a benchmark linear model of baseline age and BCVA. Quantitative OCT features were derived by a DL segmentation model on the volume images, including retinal layer volumes and thicknesses, and retinal fluid biomarkers, including statistics on fluid volume and distribution. Main outcome measures: Prognostic ability of the models was evaluated using coefficient of determination (R Results: In the first cross-validation split, mean R Conclusions: Machine learning models based on AI-segmented OCT features and clinical variables at baseline may predict future response to ranibizumab treatment in patients with nAMD. However, further developments will be needed to realize the clinical utility of such AI-based tools. Financial disclosures: Proprietary or commercial disclosure may be found after the references.
Language	English
Publishing date	2023-04-21
Publishing country	Netherlands
Document type	Journal Article
ISSN	2666-9145
ISSN (online)	2666-9145
DOI	10.1016/j.xops.2023.100319
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Article ; Online: Impact of Prophylactic Ranibizumab to Prevent Neovascular Age-Related Macular Degeneration on Eyes With Intermediate Age-Related Macular Degeneration.

Chan, Clement K / Beaulieu, Wesley T / Lujan, Brandon J / Lalezary, Maziar / Lent-Schochet, Daniella / Lo, Therlinder / Yiu, Glenn

Translational vision science & technology

2023 Volume 12, Issue 9, Page(s) 1

Abstract: ... injections given every 3 months in eyes with intermediate nonexudative age-related macular degeneration (AMD ... on drusen volume, macular layer thicknesses, and progression of geographic atrophy (GA) area over 24 months ... with intermediate AMD randomized to PR versus sham injections to determine rates of conversion to neovascular AMD ...

Abstract	Purpose: The purpose of this study was to determine the impact of prophylactic ranibizumab (PR) injections given every 3 months in eyes with intermediate nonexudative age-related macular degeneration (AMD) on drusen volume, macular layer thicknesses, and progression of geographic atrophy (GA) area over 24 months in the PREVENT trial. Methods: This post hoc analysis of the prospective PREVENT trial compared eyes with intermediate AMD randomized to PR versus sham injections to determine rates of conversion to neovascular AMD over 24 months. Drusen area and volume, macular thickness and volume, and retinal layer thicknesses were measured on spectral-domain optical coherence tomography images and analyzed. Masked grading of GA area and subretinal drusenoid deposits (SDDs) using fundus autofluorescence images was performed. Results: There were no statistical differences in drusen area and volumes between groups, and similar reductions in central subfield thickness, mean cube thickness, cube volume, and retinal sublayer thickness from baseline to 24 months (P = 0.018 to < 0.001), with no statistical differences between groups in any of these anatomic parameters. These findings were not impacted by the presence or absence of SDD. Among the 9 eyes with GA in this study, mean GA growth rate from baseline to 24 months was 1.34 +/- 0.79 mm2/year after PR and 1.95 +/- 1.73 mm2/year in sham-treated eyes (P = 0.49), and similarly showed no statistical difference with square root transformation (P = 0.61). Conclusions: Prophylactic ranibizumab given every 3 months did not appear to affect drusen volume, macular thinning, or GA progression in eyes with intermediate AMD. Translational relevance: This work investigates the impact of PR on progressive retinal degeneration in a clinical trial.
MeSH term(s)	Humans ; Child, Preschool ; Ranibizumab/therapeutic use ; Angiogenesis Inhibitors/therapeutic use ; Prospective Studies ; Vascular Endothelial Growth Factor A ; Visual Acuity ; Wet Macular Degeneration/diagnosis ; Wet Macular Degeneration/drug therapy ; Retina/diagnostic imaging ; Geographic Atrophy
Chemical Substances	Ranibizumab (ZL1R02VT79) ; Angiogenesis Inhibitors ; Vascular Endothelial Growth Factor A
Language	English
Publishing date	2023-09-01
Publishing country	United States
Document type	Randomized Controlled Trial ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2674602-5
ISSN	2164-2591 ; 2164-2591
ISSN (online)	2164-2591
ISSN	2164-2591
DOI	10.1167/tvst.12.9.1
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