CLINICAL TRIALS

WHAT IS A CLINICAL TRIAL?

Clinical trials are conducted in order to collect data on the safety and efficacy of new pharmacological or surgical therapies, or on new diagnostic strategies; in the case of the Bietti Foundation, their scope is ophthalmological. 

WHY APPLY FOR RECRUITING?

Volunteers have a leading role in research. In addition to contributing to research, they can participate in the most innovative treatments 

WHY THE FOUNDATION CONDUCTS CLINICAL TRIALS?

As an IRCCS research institute, the Bietti Foundation initiates numerous clinical trials in order to analyse the advantages, disadvantages, benefits and risks of treatments through the administration of drugs under examination, through new surgical techniques or through diagnostic-instrumental investigations on voluntary human subjects. 

WHY IS IT USEFUL FOR RESEARCH?

The clinical trial is the latest step in the path of approval of therapies and drugs, and confers the latest answers to the investigations carried out in the laboratory. 

 

 

Open clinical trials for recruiting

UR GLAUCOMA
  • TRITON – A Phase 3b Study to Evaluate the Duration of Effect of Bimatoprost SR in Participants with Open- Angle Glaucoma or Ocular Hypertension
  • GLC 04-20 – Valutazione dell’agreement tra diverse griglie perimetriche nell’identificare il difetto funzionale centrale in pazienti glaucomatosi con riduzione dello spessore delle cellule ganglionari misurato con tomografia a coerenza ottica spectral-domain 
  • β-amiloide – Valutazione della concentrazione di β-amiloide e di pathways proteolitici intracellulari su tessuti e fluidi oculari di pazienti sottoposti a intervento chirurgico di glaucoma combinato o meno ad intervento di cataratta (Beta-amiloide) 
  • CMP_005 – An observational prospective longitudinal study for the clinical evaluation of visual field change in glaucoma. An assessment of different models of progression 
  • Velux – Automatic evaluation of the anterior chamber angle width by a new non-contact optical device. 
  • OMK1P3 – A phase III multicenter, double-blind, randomized, placebo-controlled, parallel-group trial of the efficacy of citicoline eyedrops2%on visual field preservation in patients with open angle glaucoma 
  • IS06-21-01 – Evaluation of performance and safety of IRIDIUM® A gel preservative-free ophthalmic solution in patients with glaucoma or ocular hypertension and concomitant dry eye syndrome on multiple long-term topical hypotensive therapy: a prospective, multicentric, open-label clinical investigation. 
  • BIM-001 – Randomized, open label, parallel-group, two-arm,multicenter, study with clinical endpoint comparing preservative free Bimatoprost ophthalmic solution 0.1mg/ml and Lumigan® (Bimatoprost ophthalmic solution) 0.1 mg/ml in patients with chronic open-angle glaucoma or ocular hypertension in one or both eyes (BIM-001).
  • GLC 06-23 – Efficacia e sicurezza del dispositivo XEN63: studio prospettico osservazionale multicentrico.
  • Ippocrate – Valutazione a lungo termine dei cambiamenti morfologici, funzionali e vascolari in pazienti ipertesi oculari e glaucomatosi. Studio IPPOCRATE.
  • SEA 01-22 – Studio caso-controllo della fisiopatologia corneale mediante tecniche di diagnostica strumentale in soggetti sani ed in pazienti affetti da patologie oculari e/o da malattie sistemiche. Fisiopatologia corneale
  • INTERCEPT – A collaborative resource of Heidelberg multimodal imaging of Intermediate AMD with and without early atrophy to study prediction of disease progression
  • PORTAL – a multicenter, open-label extension study to evaluate the long-term safety and tolerability of the port delivery system with ranibizumab in patients with neovascular age-related macular degeneration
  • MACUSTAR – Sviluppo di nuovi endpoint clinici per sperimentazioni cliniche interventistiche con intento regolatorio e di accesso al paziente in soggetti con Degenerazione Maculare Senile Intermedia
  • RET 03-19 – Cross-sectional and longitudinal case–control exploratory clinical study:Morphological retinal changes in type 1 diabetes evaluated by means of multimodal imaging_DM1
  • RECOGNISED Retinal and cognitive dysfunction in type 2 diabetes: unraveling the common pathways and identification of patients at risk of dementia
  • RET 02-21 – Valutazione Morfo-Funzionale della Retina e della coroide mediante Imaging Multimodale in soggetti sani e in pazienti con patologie retino-coroideali
  • COAST – Studio di fase 3, multicentrico, in doppio cieco, randomizzato volto a valutare l’efficacia e la sicurezza    di OPT-302 Intravitreale in combinazione con Aflibercept, rispetto ad Aflibercept in monoterapia, in partecipanti con degenerazione maculare neovascolare correlata all’età (NAMD).
  • PASCAL – Subthreshold laser treatment for reticolar pseudodrusen secondary to age related macular degeneration
  • HONU – A multicenter, prospective, observational study of the progression of intermediate age-related macular degeneration
  • PTA – PROGRAMMA DI POST TRIAL ACCESS in regime di uso Terapeutico con faricimab “Protocollo AG43397 (Parte B) per l’accesso Post-Trial in regime di uso terapeutico con Faricimab per pazienti affetti da edema maculare secondario all’occlusione venosa retinica di branca o centrale (BRVO e CRVO).
  • GAL-21-NIS – Geographic Atrophy Long-Term Outcomes Study: an ambispective non-interventional study to describe the patient demographics, baseline characteristics, and outcomes of patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) in clinical practice
  • R.O. Project – Identificazione e validazione di biomarcatori in patologie oftalmologiche (degenerazione maculare legata all’età, retinopatia diabetica e distacco retinico) tramite approcci di proteomica clinica
  • INITIATE – A Multi-country, Post Marketing Observational Study of DME Patients with Suboptimal Response to anti-VEGF who are initiated with Dexamethasone intravitreal implant (DEX-I)
  • VOYAGER – Real-world, long-term data collection To gain clinical insights into roche Ophthalmology products (voyager Study)
  • QUASAR – Randomized, double-masked, active-controlled, phase 3 study of the efficacy and safety of Aflibercept 8 mg in macular edema secondary to retinal vein occlusion
  • POYANG – A Phase III, multicenter, randomized, doble masked, active comparator-controlled study to evaluate the efficacy and safety of Faricimab in patients with Choroidal Neovascularization seconday to Patologic Myopia
  • RET 06-24 – Valutazione dell’impatto della riabilitazione visiva sull’entità di ansia e depressione in pazienti ipovedenti da degenerazione maculare legata all’età (AMD) evoluta.
  • ASCENT – A randomized, partially masked, controlled, phase 3 clinical study to evaluate the efficacy and safety of RGX-314 gene therapy in partecipant with nAMD (ASCENT)
  • RET 09-23 – Assessing Clinical Outcomes and Imaging Characteristics in Central Serous Chorioretinopathy by Ethnicity
  • VELODROME – a phase iiib, global, multicenter, randomized, visual assessor−masked study of the efficacy, safety, and pharmacokinetics of a 36-week refill regimen for the port delivery system with ranibizumab in patients with neovascular age-related macular degeneration (velodrome)
  • CRIMSON – CRIMSON: A multicentre, randomised, sham-controlled (and active controlled in the USA), double-masked, 72-week trial to study the safety, tolerability, pharmacokinetics, and efficacy of 3 dosing regimens of intravitreal BI 764524 in patients with moderately severe to severe non-proliferative diabetic retinopathy
  • CLIN-ITEMS – Correlation between silicone-oil related ocular complications and ITMES score
  • CARTESIO – Modulazione della connettività neuronale lungo le vie ottiche nei pazienti glaucomatosi tramite trattamento con Citicolina in soluzione orale: studio Morfo-Funzionale Multimodale
  • WGS in IRDs – Understanding Genetic Missing Variability and Pathogenetic Mechanisms of Inherited Retinal Dystrophies Using Whole Genome Sequencing and in Vitro and in Vivo Models
  • Micropulsato – Treatment of macular oedema in patients with hereditary retinal dystrophies by applying the micropulsed subthreshold laser
  • AISA – Identificazione del coinvolgimento morfo-funzionale retinico in pazienti affetti da atassia di Friedreich (AF) in età precoce di malattia e nei pazienti adulti.
  • NOPRODRPG0002 – Global Patient Registry of Inherited Retinal Disease
  • TAKEDA – A Randomized, Double-blind, placebo-controlled, phase II study to evaluated the efficacy, safety, tollerability, pharmacokinetics and pharmacodinamics of intravenus TAK-341 in subjects with multiple system atrophy
  • NEU 01-24 – Valutazione della stato morfo-funzionale maculare in pazienti con sclerosi multipla senza neurite ottica retrobulbare
  • NEU 03-24 – Assessing central neuromodulation effects on immune-mediated synaptic dysfunction in progressive multiple sclerosis
  • 5M-2021-23683505 – Dalla pratica clinica al laboratorio: un percorso inverso per la ricerca di biomarcatori nel distacco di retina e sviluppo di colture cellulari con l’utilizzo di fluidi oculari
  • 5M-2020-23681919 – Caratterizzazione molecolare e funzionale del sistema ubiquitina proteasoma durante il danno ipossico in un modello sperimentale di glia di Muller
  • BASE 04-23 – Approfondimento strutturale e funzionale dell’interazione Citicolina proteasoma e sintesi e sviluppo di derivati chimici della molecola”
  • BASE 01-24 – Sviluppo ed applicazione di workflows di “N-tail terminomics” per la caratterizzazione di eventi proteolitici di rilevanza patologica in patologie oculari.
  • PRO 01-25 – Effect of a Physiotherapy Program Based on Concurrent Training of Moderate-High Intensity Strength and Aerobic Exercise, Combined with a Cohesive Bandage, in Women with Breast Cancer-Related Lymphedema
  • TEARPLAY – Tear-film Evolution in Antarctic Region: biostrumental, biochemical and behavioural PLAYers

 

A Phase III, multicenter, randomized, double-masked, active comparator-controlled study to evaluate the efficacy and safety of faricimab in patients with macular edema secondary to central or hemiretinal retinal vein occlusion 

Characterization of retinal disease progression in patients with non-proliferative diabetic retinopathy (npdr) in type 2 diabetes using non-invasive procedures 

Assessment of patient satisfaction in the management of wet age-related macular degeneration: survey of Italian patients.

Retinal and Cognitive Dysfunction in Type 2 Diabetes: unveiling common pathways and identifying patients at risk for dementia. 

Basic human research study of new endpoints in glaucoma and identification of optimal patient populations for neuroprotective trials 

A Phase 3b study to evaluate the duration of effect of bimatoprost SR in participants with open-angle glaucoma or ocular hypertension 

Evaluation of the efficacy and safety of eye drops T4030 compared to single-dose Ganfort in patients with ocular hypertension or glaucoma.

XEN Glaucoma Treatment Registry (XEN-GTR)

24-hour efficacy and tolerability of the fixed combination tafluprost
-timolol without preservatives in glaucomatous or ocular hypertensive patients already treated with BAK preserved latanoprost. Prospective 3-month study.

Clinical trial to study the visual performance of hydrophobic monofocal IOL: Micropure 1.2.3.

Evaluation of the agreement between different Amsler grids in identifying the central functional defect in glaucomatous patients with reduction of the thickness of the ganglion cells measured with spectral-domain optical coherence tomography.

Assessment of β-amyloid concentration and intracellular proteolytic pathways in tissues and eye fluids of patients undergoing glaucoma surgery combined or non-combined with cataract surgery 

Case-control study of corneal pathophysiology using instrumental diagnostic techniques in healthy subjects and in patients suffering from ocular diseases and/or systemic diseases Imagine One-year, multicenter, single-arm, phase IV open-label study to identify early and innovative anatomical biomarkers predictive of retinal fluid resolution by multimodal imaging and support assessment of pathology activity in wAMD and patients treated with brolucizumab (IMAGINE Study) 

Evaluation of the effects and tolerability of RD03/2016 (Levofloxacin; Ketorolac Trometamol 0.5+0.5% w/v eye drops in solution) for the treatment of bacterial conjunctivitis in adults: a multicenter, randomized, blinded, phase II non-inferiority study – MIRACLE.

One-year, multicenter, single-arm, phase IV open-label study to identify early and innovative anatomical biomarkers predictive of retinal fluid resolution by multimodal imaging and support assessment of pathology activity in wAMD and patients treated with brolucizumab (IMAGINE Study).

Phase 3 follow-up study of aav5-hrkp.rpgr for the treatment of x-linked retinitis pigmentosa associated with rpgr gene variants. 

Randomized, phase 3 controlled trial of AAV5-hRKp.RPGR for the treatment of X-linked retinitis pigmentosa associated with RPGR gene variants 

Modulation of neuronal connectivity along the visual pathways in glaucomatous patients by treatment with Citicoline oral solution: Multimodal Morpho-Functional study 

Observational study of neurodegenerative processes in patients with retinal and/or visual nervous system pathologies through innovative methods of morpho-functional evaluation of the different retinal elements and the different components of the optical pathways 

A Phase 3, multi-center, double-blind, randomized study to evaluate the efficacy and safety of intravitreal OPT-302 in combination with Aflibercept, compared to Aflibercept monotherapy, in participants with age-related neovascular macular degeneration (NAMD) 

A Phase 2, randomised, multi-centre study to assess the dose level of multiple THR-149 injections and to evaluate the efficacy and safety of THR-149 versus aflibercept for the treatment of diabetic macular oedema (DME) 

Real-world study on anti-vegf treatments in neovascular age-related macular degeneration in Italy: real clinical practice analysis: The Radiance Study 

Evaluation of the efficacy of hypnosis of the PreserFlo device in combination or not with cataract surgery in glaucomatous patients: a multicenter retrospective “before-after” study.

Longitudinal prospective observational study for clinical assessment of visual field change in glaucoma. Evaluation of different progression models 

Evaluation of spatial summation in the central 10 degrees of the visual field: development of a neural model for structure-function analysis.

Performance of DRS Plus Retinography in Patients with Diabetes Mellitus.

Development of new clinical endpoints for interventional clinical trials with regulatory intent and patient access in subjects with intermediate macular degeneration (AMD) 

A multicenter, open-label extension study to evaluate the long-term safety and tolerability of Faricimab in patients with diabetic macular edema 

Open-label, multicenter extension study to evaluate the long-term safety and tolerability of FARICIMAB in patients with neovascular age-related macular degeneration 

Evaluation of a prolonged and proactive dosing regimen in treatment-naïve patients with wet age-related macular degeneration (wAMD) 

Sub-threshold laser treatment for reticular Pseudodrusen secondary to age-related macular degeneration. 

Evaluation of hormones and inflammatory mediators on corneal tissue and in ocular fluids (tear and aqueous humor) of patients undergoing corneal transplantation 

Automatic assessment of the width of the anterior chamber angle using a new non-contact screening tool 

ISO6_21_01 (IRIDIUM GEL) 

Evaluation of the performance and safety of IRIDIUM® gel, an ophthalmic solution without gel preservatives, in patients with glaucoma or ocular hypertension and concomitant dry eye syndrome in long-term multiple topical hypotensive therapy: a prospective, multicenter, open-label clinical investigation. 

Quality of life and glaucoma: patient-centered qualitative assessment approach 

Multicenter, randomized, double-blind, Vehicle-Controlled, Active Phase 3 Study Evaluating the Efficacy and Safety of Ketotifen Ophthalmic Solution 0.5 mg/mL Compared to Vehicle and Ketoftil (Ketotifen Ophthalmic Solution 0.5 mg/mL) for the Treatment of Seasonal Allergic Conjunctivitis 

Morpho-functional assessment of the retina and choroid by multimodal imaging in healthy subjects and patients with retinochoroidal diseases 

Multicenter, prospective, observational study on the progression of the intermediate age-related macular degeneration 

Geographic atrophy long-term outcome study (Galtos): non-interventional ambispective study to derive patient demographics, baseline characteristics and outcomes of patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) in clinical practice.  

Biomarkers discovery and validation in ophthalmological diseases (age-related macular degeneration, diabetic retinopathy and retinal detachment) through clinical proteomics approaches Vmd in the elderly.  

Mechanisms of hereditary retinal dystrophies using genome-wide sequencing and in vitro and in vivo models Micropulse Laser Treatment of macular edema in patients with inherited retinal dystrophies by applying the subthreshold micropulse laser treatment

Evaluation of the agreement between different Amsler grids in identifying the central functional defect in glaucomatous patients with reduction of the thickness of the ganglion cells measured with spectral-domain optical coherence tomography. 

A Phase III, double-blind, randomized, placebo-controlled, Parallel Group, Multicenter Study of the Efficacy of Citicoline Glasses 2% on Visual Field Preservation in Patients with Omk1p3 Open Angle Glaucoma 

A randomized, open-label, parallel-group, two-arm, multicenter, clinical endpoint study comparing Bimatoprost 0.1 mg/ml preservative-free ophthalmic solution and Lumigan® (Bimatoprost ophthalmic solution) 0.1 mg/ml in patients with chronic open-angle glaucoma or ocular hypertension in one or both eyes (BIM-001). 

Visual results and optical characteristics of a new “enhanced” monofocal hydrophobic acrylic intraocular lens 

Case-Section and Longitudinal-Control Explanatory Clinical Study: Morphological Retinal Changes in Type 1 Diabetes Evaluated by Multimodal Imaging_dm1 

Randomized, double-blind, active-controlled, phase 3 study of the efficacy and safety of high-dose aflibercept in patients with neovascular age-related macular degeneration CLINICAL STUDY 20968 – PULSAR 

A longitudinal study on anti-vegf biomarkers, to explore the relationship between aqueous mood composition and multimodal retinal immaging in age-related neovascular macular degeneration and diabetic macular edema 

Performance of DRS Plus Retinography in Patients with Diabetes Mellitus 

A multinational post-marketing observational study of DME patients with suboptimal response to anti-VEGFs who initiated intravitreal Dexamethasone intravitreal implant (DEX-I) 

Real and long-term data collection. Gain clinical knowledge about Roche Ophthalmology products (Voyager study) 

A Phase 3, randomized, double-blind, active-controlled study of theefficacy and safety of Aflibercept 8 mg in macular edema secondary to retinal vein occlusion 

A collaborative Heidelberg multimodal imaging resource of intermediate AMD with and without early atrophy to study the prediction of disease progression 

Evolution of the tear film in the Antarctic region: biostrumental, biochemical and behavioural actors. 

From clinical practice to the laboratory: an inverse path for the research of biomarkers in retinal detachment and development of cell cultures with the use of eye fluids 

Molecular and functional characterization of the ubiquitin-proteasome system during hypoxic injury in an experimental model of Muller Glia  

Structural and functional deepening of the Citicoline proteasome interaction and synthesis and development of chemical derivatives of the molecule” 

 

Complete list of Foundation trials

As IRCCS, the G.B. Bietti Foundation has made research the beating heart of its activity. Our priority is to solve the still unanswered questions about pathologies, treatments, cures, and medicines. That’s why clinical trials are an essential part of our business in building effective and safe health for all.

Trials
Status
Performance of DRS Plus Retinography in Patients with Diabetes Mellitus
Opened with enrollment completed
Macustar
Opened with enrollment completed
Trial 3
Closed/Concluded