AG Klinische Studien
Die Arbeitsgruppe "Klinische Forschung" beschäftigt sich mit der Durchführung von klinischen Studien sowie der phänotypischen Charakterisierung von Patient*innen mit Erkrankungen des Auges und der Durchführung von klinischen Studien neuer Behandlungsmethoden bei Patient*innen mit gut charakterisierten Symptomen zur Bewertung der Wirksamkeit der therapeutischen Anwendung
| Mitarbeiter*innen | |
|---|---|
| Prof. Dr. Lyubomyr Lytvynchuk PhD | Direktor der Klinik |
| Dr. Monika Andrassi-Darida | Oberärztin |
| Dr. Christoph Friedburg | Oberarzt |
| PD Dr. Dipl.-Biol. Markus Preising | Studienkoordinator |
| Kerstin Holve | Orthoptistin |
| Kerstin Lenz | Sekretariat Forschung und Lehre |
| Sandra Schütz | Leitung bildgebende Diagnostik |
Themen:
- Teilnahme an multizentrischen klinischen Versuchen für neuartige ophthalmologische Medikamente
- Studien zum natürlicher Verlauf erblicher Netzhauterkrankungen mithilfe multimodaler Meßmethoden (Spectralis OCT, MP1 Microperimetrie)
- Phänotypisierung von frühkindlichen Netzhauterkrankungen mithilfe neuester Meßmethoden (Spectralis OCT, MP1 Microperimetrie)
Aktive klinische Studien:
| CoRaLaII (2020-000681-42) Link |
Long-term need of Ranibizumab injections with or without early targeted peripheral laser photocoagulation for treatment of macular edema due to central retinal vein occlusion |
Justus-Liebig University Gießen |
|
Perceive |
Post-Authorization, Multicenter, Multinational, Longitudinal, Observational Safety Registry Study for Patients Treated with Voretigene Neparvovec (NIS/PASS). |
Novartis |
|
Vertex |
A Phase 3, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation |
Vertex Pharmaceuticals Incorporated |
|
OSPREY
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An Open-label Study to Investigate the Safety, Tolerability, and Exposure of Single Ascending Doses of the Antisense Oligonucleotide STK-002 in Patients with Autosomal Dominant Optic Atrophy | Stoke Therapeutics |
|
HYDRA |
A post-market clinical study to collect safety and performance data on Johnson & Johnson Surgical Vision products |
Johnson & Johnson |
|
LHON |
A Non-interventional Multi-center Study Evaluating Clinical Treatment with Idebenone in Patients with Chronic Leber’s Hereditary Optic Neuropathy | Medizinische Universität Wien Universitätsklinik für Augenheilkunde und Optometrie |
Unterstützung weiterer Studien an der JLU Gießen:
|
PARASOL
|
A Phase 2b, Randomized, Double-masked, |
Janssen Research & Development, LLC |
| TROPION (EUDRACT 2020-004643-80) |
Phase 3 Randomized Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer without Actionable Genomic Alterations | Daiichi Sankyo, Inc. |
|
Sasanlimab |
A Phase 1b/2 Open Label Umbrella Study of Sasanlimab Combined with Anti-Cancer Therapies Targeting Multiple Molecular Mechanisms in Participants with Non-Small Cell Lung Cancer (NSCLC) |
Pfizer Inc. |
|
REZELIENT-2 |
An Open-Label, Phase 2b, Global Multicenter Cohort Trial to Assess the Safety and Efficacy of Zipalertinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Exon 20 Insertion and Uncommon/Single or Compound Epidermal Growth Factor Receptor Mutations | Taiho Oncology, Inc. |
|
PALOMA |
Previosly Untreated MET Amplified Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer |
Abbvie Deutschland GmH & Co. KG |
| IST-06 (EUDRACT 2020-005496-13) |
A Randomised, Double-Blind, Placebo-Controlled, Dose-Ranging Phase 2b Study to Investigate the Efficacy & Safety of MBS2320 in Participants With Moderate to Severe Active Rheumatoid Arthritis With Inadequate Response to Methotrexate Alone | Modern Biosciences Ltd. |
|
M18-868 |
A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects with Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Adva | AbbVie Deutschland GmbH & Co. KG |
|
PERSEUS |
OCT bei Patienten mit multipler Sklerose |
Sanofi/Genzyme LMU München |
Abgeschlossene klinische Studien
| EDITAS | Natrual History Study of CEP290-Related Retinal Degeneration | Allergan Inc |
|
AURIGA |
An observational study program to investigate the effectiveness of intravitreal Aflibercept in diabetic macular edema and/or macular edema secondary to retinal vein occlusion in a real world setting |
Bayer |
|
Nachfolge LYNX |
Langzeit-Beobachtungsstudie von Latanoprost zur Überwachung von Veränderungen der Hyperpigmentierung am Auge bei pädiatrischen Populationen |
Pfizer |
|
Die Konzentration von Wachstumsfaktoren und radikalen Sauerstoffspezies in verschiedenen Körperflüssigkeiten bei extrem unreifen Frühgeborenen und ihre Rolle bei der okulären Angiogenese |
Von Behring-Röntgen-Stiftung | |
|
WAVE |
Lucentis in wet AMD: Evaluation of Visual Acuity and Quality of Life |
Novartis |
|
ACYTER |
Clinical Efficacy and Safety of Acyter (Azitrhomycine 1,5%) versus Tobramycin 0,3% Eye drops in the treatment of purulent bacterial conjunctivitis in children |
Théa |
|
PANDA |
Phase III prospective, randomized, double masked 12 week parallel group study evaluating the efficacy and safety of Latanoprost and Timolol in pediatric subjects with glaucoma |
Pfizer |
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COMPASS |
Phase IV Lucentis - research study for wet AMD: Influence of the referring Ophthalmologist within the network of wet AMD |
Novartis |
| DRAGON (2021-003253-36) Link |
Phase 3, Multicenter, Randomized, Double- |
Belite Bio, Inc |
| RELATION |
A 12-month, two-armed, randomized, double-masked, multicenter, Phase IIIb study assessing the efficacy and safety of laser photocoagulation as adjunctive to Ranibizumab intravitreal injections vs. laser photocoagulation monotherapy in patients with visual impairment due to diabetic macular edema followed by a 12 month follow up period |
Novartis |
|
COMRADE |
A 6-month multicenter, randomized, double-masked phase IIIb-study comparing the efficacy and safety ofLucentis(Ranibizumab) intravitreal injections versusOzurdex(Dexamethasone) intravitreal implant in patients with visual impairment due to macular edema following branch retinal vein occlusion |
Novartis |
|
POLARIS |
Eine prospektive nicht-interventionelle Studie zur Bewertung der Wirksamkeit von existierenden antivascular endothelial growth factor (anti-VEGF)-Behandlungsregimen bei Patienten mit diabetischem Makulaödem (DMÖ) mit zentraler Beteiligung |
Bayer |
|
Lumeos |
Randomisierte, kontrollierte Phase-3-Studie zu AAV5-hRKp.RPGR zur Behandlung von X-chromosomaler Retinitis pigmentosa in Verbindung mit RPGR-Genvarianten Phase-3-Folgestudie zu AAV5-hRKpRPGR zur Behandlung von X-chromosomaler Retinitis pigmentosa in Verbindung mit RPGR-Genvarianten. |
MeiraGTx UK II Limited |
|
LYNX |
A Prospective, non-interventional, longitudinal cohort study to evaluate the long-term safety of Xalatan® treatment in pediatric populations |
Pfizer |
|
MINERVA |
A 12-month, randomized, double-masked, sham-controlled, multicenter study to evaluate the efficacy and safety of 0.5 mg ranibizumab intravitreal injections in patients with visual impairment due to vascular endothelial growth factor (VEGF) driven choroidal neovascularization (CNV) |
Novartis |
|
PROMETHEUS |
A 12-month, randomized, double-masked, sham-controlled, multicenter study to evaluate the efficacy and safety of 0.5 mg ranibizumab intravitreal injections in patients with visual impairment due to vascular endothelial growth factor (VEGF) driven choroidal neovascularization (CNV) |
Novartis |
|
Illuminate |
Eine doppelblinde, randomisierte, kontrollierte Mehrfachdosis-Studie zur Beurteilung der Wirksamkeit, Sicherheit, Verträglichkeit und systemischen Exposition von |
ProQR Therapeutics |
|
Brighten |
An Open-Label, Dose Escalation and Double-Masked, Randomized, Controlled |
ProQR Therapeutics |
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MGT-RPGR-023 |
Studie zur Ermittlung der Anwesenheit von genetisch bestätigten RPGRassoziierten MeiraGTx UK II Limited |
MeiraGTx UK II Limited |
|
Amethist |
A multicenter, multinational, randomized, double-blind, placebocontrolled study to assess the efficacy, pharmacodynamics, pharmacokinetics, safety, and tolerability of venglustat in late-onset GM2 gangliosidosis (Tay-Sachs disease and Sandhoff disease) together with a separate basket for juvenile/adolescent late-onset GM2 gangliosidosis and ultra-rare diseases within the same and similar glucosylceramide-based sphingolipid pathway |
Genzyme Corporation |
|
INTERCEPT-AMD |
Eine gemeinschaftliche Sammlung von Daten aus |
AIBILI |
|
Vertex |
A Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation - IE |
Vertex Pharmaceuticals Incorporated |