Intézetünk 2007-es indulása óta több, mint 100 nemzetközi kutatási projekt résztvevője volt, tevékenységünkért díjakat is elnyertünk.
Minden nálunk dolgozó, a kutatásokban résztvevő orvos és nem orvos kolléga rendszeres, a klinikai kutatásokkal kapcsolatos továbbképzésben részesül (GCP: Good Clinical Practice és más, a kutatásokhoz fontos képzések).
A szóban forgó készítményekkel kapcsolatban kollégáink az átlagosat jelentősen meghaladó jártassággal, tapasztalattal rendelkeznek.
és ennek tényét jogszerűen nyilvánosságra hozhatjuk:
Intravitreal Aflibercept (VEGF Trap-Eye) in Wet Age-related Macular Degeneration. Ophthalmology, Volume 119, Issue 12, 2537 - 2548
Garweg JG, Štefanickova J, Hoyng C, Niesen T, Schmelter T, Leal S, Sivaprasad S; VIOLET Investigators. Dosing Regimens of Intravitreal Aflibercept for Diabetic Macular Edema Beyond the First Year: VIOLET, a Prospective Randomized Trial. Adv Ther. 2022 Jun;39(6):2701-2716. doi: 10.1007/s12325-022-02119-z. Epub 2022 Apr 12. PMID: 35412227; PMCID: PMC9123040. (fulltext)
Garweg JG, Stefanickova J, Hoyng C, Schmelter T, Niesen T, Sowade O, Sivaprasad S; AQUA Investigators. Vision-Related Quality of Life in Patients with Diabetic Macular Edema Treated with Intravitreal Aflibercept: The AQUA Study. Ophthalmol Retina. 2019 Jul;3(7):567-575. doi: 10.1016/j.oret.2019.03.012. Epub 2019 Mar 21. PMID: 31080168. (fulltext)
Ogura Y, Roider J, Korobelnik JF, Holz FG, Simader C, Schmidt-Erfurth U, Vitti R, Berliner AJ, Hiemeyer F, Stemper B, Zeitz O, Sandbrink R; GALILEO Study Group. Intravitreal aflibercept for macular edema secondary to central retinal vein occlusion: 18-month results of the phase 3 GALILEO study. Am J Ophthalmol. 2014 Nov;158(5):1032-8. doi: 10.1016/j.ajo.2014.07.027. Epub 2014 Jul 25. PMID: 25068637. (https://www.ajo.com/article/S0002-9394(14)00448-6/fulltext#%20)
Intravitreal Aflibercept 8 mg in Neovascular Age-Related Macular Degeneration. Korobelnik, Jean-François et al. Ophthalmology, Volume 133, Issue 1, 39 - 50
Diana V. Do, Charles C. Wykoff, Sobha Sivaprasad, David M. Brown, David S. Boyer, Taiji Sakamoto, Peter Win, Sunir Joshi, Hani Salehi-Had, András Seres, Sergio Leal, Robert Vitti, Karen W. Chu, Kimberly Reed, Yenchieh Cheng, Rafia Bhore, Zhanying Bai, Ursula Schmidt-Ott, Thomas Schmelter, Andrea Schulze, Zoran Hasanbasic, Peter J. Morgan-Warren, Xin Zhang, Alyson J. Berliner, on behalf of the PHOTON Investigators. Plain language summary of publication of the 96-week results from the PHOTON study: intravitreal aflibercept 8 mg for diabetic macular edema. Therapeutic Advances in Ophthalmology, accepted for publication 2026 April.
Diana V. Do, MD, Charles C. Wykoff, MD, PhD, Sobha Sivaprasad, FRCOphth, David M. Brown, MD, David S. Boyer, MD, Taiji Sakamoto, MD, Peter Win, MD,7 Sunir Joshi, MD,8 Hani Salehi-Had, MD, András Seres, MD, Alyson J. Berliner, MD, PhD, Sergio Leal, MD, Robert Vitti, MD, Karen W. Chu, MS, Kimberly Reed, OD, Yenchieh Cheng, PhD, Rafia Bhore, PhD, Zhanying Bai, MS, Ursula Schmidt-Ott, MD, Thomas Schmelter, PhD, Andrea Schulze, MS, Zoran Hasanbasic, MD, Peter J. Morgan-Warren, PhD, FRCOphth, Xin Zhang, MD, Boaz Hirshberg, MD, George D. Yancopoulos, MD, PhD, on behalf of the PHOTON Investigators. Intravitreal Aflibercept 8 mg for Diabetic Macular Edema. Ninety-Six-Week Results from the Randomized Phase 2/3 PHOTON Trial. Ophthalmology, https://doi.org/10.1016/j.ophtha.2025.10.028
David M. Brown, David S. Boyer, Diana V. Do, Charles C. Wykoff, Taiji Sakamoto, Peter Win, Sunir Joshi, Hani Salehi-Had, András Seres, Alyson J. Berliner, Sergio Leal, Robert Vitti, Karen W. Chu, Kimberly Reed, Rohini Rao, Yenchieh Cheng, Delia Voronca, Rafia Bhore, Ursula Schmidt-Ott, Thomas Schmelter, Andrea Schulze, Xin Zhang, Sobha Sivaprasad, on behalf of the PHOTON Investigators. Plain Language Summary of Publication of the 48-Week Results From the PHOTON Study: Intravitreal Aflibercept 8 mg For Diabetic Macular Edema. Accepted for publication in Therapeutic Advances in Ophthalmology 2025 MAY. https://journals.sagepub.com/doi/10.1177/25158414251347689
Silva R, Axer-Siegel R, Eldem B, Guymer R, Kirchhof B, Papp A, Seres A, Gekkieva M, Nieweg A, Pilz S, SECURE Study Group;: The SECURE Study: Long-Term Safety of Ranibizumab 0.5 mg in Neovascular Age-Related Macular Degeneration; Ophthalmology (Sep 2012) Ophthalmology, Volume 120, Issue 1, 130 - 139
Paul Mitchell 1, Neil Bressler, Keith Tolley, Meghan Gallagher, Jennifer Petrillo, Alberto Ferreira, Robert Wood, Francesco Bandello; RESTORE Study Group: Patient-reported visual function outcomes improve after ranibizumab treatment in patients with vision impairment due to diabetic macular edema: randomized clinical trial. JAMA Ophthalmol 2013 Oct;131(10):1339-47.
Singer M., Albini T.A, Seres A., Baumal C.R., Parikh S., Gale R., Kaiser P.K., Lobach I., Feltgen N., Joshi M.R, Ziemssen F. & Bodaghi B., Clinical Characteristics and Outcomes of Eyes with Intraocular Inflammation after Brolucizumab: Post Hoc Analysis of HAWK and HARRIER, Ophthalmology Retina (2021), doi: https://doi.org/10.1016/j.oret.2021.05.003. (open access)
Caroline R.Baumal, Bahram Bodaghi, Michael Singer, David J.Tanzer, András Seres, Mayur R. Joshi, NicolasFeltgen, RichardGale. Expert Opinion on Management of Intraocular Inflammation, Retinal Vasculitis, and/or Vascular Occlusion after Brolucizumab Treatment. Ophthalmology Retina Available online 29 September 2020 , (Fulltext)
https://clinicaltrials.gov/ct2/show/NCT03622580
kedvező egy éves eredmények: https://www.roche.com/media/releases/med-cor-2020-12-21.htm
Tien Y. Wong, MD, PhD, Zdenka Haskova, MD, PhD, Kemal Asik, PhD, Caroline R. Baumal, MD, Karl G. Csaky, MD, PhD, Nicole Eter, MD, PhD, Jane A. Ives, MSc, Glenn J. Jaffe, MD, Jean-François Korobelnik, MD, Hugh Lin, MD, MBA, Toshinori Murata, MD, PhD, Paisan Ruamviboonsuk, MD, Patricio G. Schlottmann, MD, András I. Seres, MD, David Silverman, MSc, MBChB, Xiaodong Sun, MD, PhD, Yannan Tang, PhD, John A. Wells, MD, Young Hee Yoon, MD, PhD, Charles C. Wykoff, MD, PhD, for the YOSEMITE and RHINE Investigators: Faricimab Treat-and-Extend for Diabetic Macular Edema. Two-Year Results from the Randomized Phase 3 YOSEMITE and RHINE Trials. Ophthalmology Volume 131, Number 6, June 2024, 708-723. https://www.aaojournal.org/article/S0161-6420(23)00933-8/fulltext
Ramin Tadayoni, Liliana P. Paris, Carl J. Danzig, Francis Abreu, Arshad M. Khanani, Christopher Brittain, Timothy Y.Y. Lai, Zdenka Haskova, Taiji Sakamoto, Aachal Kotecha, Patricio G. Schlottmann, Ying Liu, András Seres, Anne-Cecile Retiere, Jeffrey R. Willis, Young Hee Yoon. Efficacy and Safety of Faricimab for Macular Edema due to Retinal Vein Occlusion: 24-Week Results from the BALATON and COMINO Trials. Ophthalmology, 2024, https://www.sciencedirect.com/science/article/pii/S0161642024000903
Lars-Olof Hattenbach, MD, PhD, Francis Abreu, PhD, Pablo Arrisi, PhD, Karen Basu, PhD, Carl J. Danzig, MD, Robyn Guymer, MD, PhD, Zdenka Haskova, MD, PhD, Jeffrey S. Heier, MD, Aachal Kotecha, PhD, Ying Liu, PhD, Anat Loewenstein, MD, András Seres, MD, Jeffrey R. Willis, MD, PhD, Charles C. Wykoff, MD, PhD, Liliana P. Paris, MD, PhD. BALATON and COMINO: Phase 3 Randomized Clinical Trials of Faricimab for Retinal Vein Occlusion: Study Design and Rationale. Ophthalmology Science, 2023. (Open access: https://www.ophthalmologyscience.org/article/S2666-9145(23)00034-9/fulltext ).
Heier JS, Khanani AM, Quezada Ruiz C, Basu K, Ferrone PJ, Brittain C, Figueroa MS, Lin H, Holz FG, Patel V, Lai TYY, Silverman D, Regillo C, Swaminathan B, Viola F, Cheung CMG, Wong TY; TENAYA and LUCERNE Investigators. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. Lancet. 2022 Feb 19;399(10326):729-740. doi: 10.1016/S0140-6736(22)00010-1. Epub 2022 Jan 24. PMID: 35085502. (link)
Wykoff CC, Abreu F, Adamis AP, Basu K, Eichenbaum DA, Haskova Z, Lin H, Loewenstein A, Mohan S, Pearce IA, Sakamoto T, Schlottmann PG, Silverman D, Sun JK, Wells JA, Willis JR, Tadayoni R; YOSEMITE and RHINE Investigators. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials. Lancet. 2022 Feb 19;399(10326):741-755. doi: 10.1016/S0140-6736(22)00018-6. Epub 2022 Jan 24. PMID: 35085503. (link)
A kutatás eredményei:
Neil M Bressler, Miroslav Veith, Jan Hamouz, Jan Ernest, Dominik Zalewski, Jan Studnička, Attila Vajas, András Papp, Gabor Vogt, James Luu, Veronika Matuskova, Young Hee Yoon, Tamás Pregun, Taehyung Kim, Donghoon Shin, Inkyung Oh, Hansol Jeong, Mercy Yeeun Kim, Se Joon Woo: Biosimilar SB11 versus reference ranibizumab in neovascular age-related macular degeneration: 1-year phase III randomised clinical trial outcomes. Br J Ophthalmol 2023;107:384–391. doi:10.1136/bjophthalmol-2021-319637 (Full text)
Se Joon Woo, MD, PhD; Miroslav Veith, MD; Jan Hamouz, MD; Jan Ernest, MD, PhD; Dominik Zalewski, MD, PhD; Jan Studnička, MD, PhD; Attila Vajas, MD; Andras Papp, MD, PhD; Vogt Gabor, MD, PhD; James Luu, MD; Veronika Matuskova, MD, PhD; Young Hee Yoon, MD, PhD; Tamás Pregun, MD; Taehyung Kim, MSc; Donghoon Shin, MD, PhD; Neil M. Bressler, MD: Efficacy and Safety of a Proposed Ranibizumab Biosimilar Product vs a Reference Ranibizumab Product for Patients With Neovascular Age-Related Macular Degeneration. JAMA Ophthalmol. 2021;139(1):68-76. doi:10.1001/jamaophthalmol.2020.5053 (fulltext)
Allergan Receives FDA Approval for DURYSTA™ (bimatoprost implant) the First and Only Intracameral Biodegradable Sustained-Release Implant to lower Intraocular Pressure in Open-Angle Glaucoma or Ocular Hypertension Patients. Press release, Allergan, 2020 Mar 05
Aerie Pharmaceuticals Announces U.S. FDA Approval of Rocklatan™ (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% for the Reduction of Intraocular Pressure in Patients with Open-Angle Glaucoma or Ocular Hypertension. Press release, Aerie, 03/12/2019
Az egyik kutatás eredményéről itt olvashatnak: https://www.aaojournal.org/article/S0161-6420(20)30845-9/fulltext?dgcid=raven_jbs_aip_email#supplementaryMaterial
Arshad M Khanani, MD, Sunil S Patel, MD, Prof Giovanni Staurenghi, MD, Prof Ramin Tadayoni, MD, Carl J Danzig, MD, David A Eichenbaum, MD et al. on behalf of theGATHER2 trial investigators: Efficacy and safety of avacincaptad pegol in patients with geographic atrophy (GATHER2): 12-month results from a randomised, double-masked, phase 3 trial. Lancet, VOLUME 402, ISSUE 10411, P1449-1458, OCTOBER 21, 2023 https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)01583-0/abstract
Khanani, Arshad M. et al. Avacincaptad pegol for geographic atrophy secondary to age-related macular degeneration: 2-year efficacy and safety results from the GATHER2 phase 3 trial Ophthalmology, https://www.aaojournal.org/article/S0161-6420(25)00790-0/fulltext
Bressler SB, Barve A, Ganapathi PC, et al. Aflibercept Biosimilar MYL-1701P vs Reference Aflibercept in Diabetic Macular Edema: The INSIGHT Randomized Clinical Trial. JAMA Ophthalmol. Published online September 12, 2024. doi:10.1001/jamaophthalmol.2024.3458
Baiama (aflibercept, Horus Pharma)
Bressler SB, Barve A, Ganapathi PC, et al. Aflibercept Biosimilar MYL-1701P vs Reference Aflibercept in Diabetic Macular Edema: The INSIGHT Randomized Clinical Trial. JAMA Ophthalmol. Published online September 12, 2024. doi:10.1001/jamaophthalmol.2024.3458 (https://jamanetwork.com/journals/jamaophthalmology/fullarticle/2823664)
Maria L. Ribeiro , Andras I. Seres, Angela M. Carneiro, Michael Stur, Alain Zourdani, Patricia Caillon, José G. Cunha-Vaz and on behalf of the DX-Retinopathy Study Group: Effect of calciumilate on progression of early diabetic retinopathy: a randomised double-blind study. Graefe’s Arch Clin Exp Ophthalmol, 2006: 244, 1591-1600.
(a kísérletben való részvételünk nyilvános információ)
A pontos kutatási részletek gyakran titkosak, tájékozódni az intézetünkben futó regisztrált kutatásokról az erre vonatkozó nemzetközi regiszterben lehet: ClinicalTrials.gov. Az adatbázis automatikusan frissülő lekérdezése (intézetünk nevére) alább látható.
Nem jelennek meg azok a vizsgálataink, amelyek esetében
a regisztráció nem az amerikai hatóságnál történt
a sponzor nem tüntette fel beadványában intézetünk teljes nevét
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