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PREvention of Macular EDema after cataract surgery

The objective of this study is to evaluate the effect of different preventive strategies on the occurrence of macular edema after cataract surgery in non-diabetic and diabetic patients.

A 24-month, phase IIIb, open-label, randomized, active-controlled,
3-arm, multicenter study assessing the efficacy and safety of an individualized,
stabilization-criteria-driven pro re nata (PRN) dosing regimen with 0.5-mg
ranibizumab intravitreal injections applied as monotherapy or with adjunctive laser
photocoagulation in comparison to laser photocoagulation in patients with visual
impairment due to macular edema secondary to branch retinal vein occlusion
(BRVO)

Primary objective:To demonstrate that an individualized stabilization-criteria-driven PRN dosingregimen (PRN) with 0.5-mg ranibizumab administered with or without adjunctive lasertreatment has superior efficacy as compared to the current standard of…

THE HYDRUS II TRIAL:
A PROSPECTIVE, MULTICENTER, RANDOMIZED CONTROLLED TRIAL TO EVALUATE THE
SAFETY AND EFFECTIVENESS OF THE HYDRUS IMPLANT FOR LOWERING INTRAOCULAR PRESSURE IN GLAUCOMA PATIENTS UNDERGOING CATARACT SURGERY

The purpose of this study is to expand knowledge of the IVANTIS Hydrus Implant's ability to decrease intraocular pressure (the pressure in the eye).

A phase IIIB, one year, open label, multicentre, noncomparative study to evaluate the safety and tolerability of intravitreal pegaptanib sodium injection in subjects with diabetic macular edema (DME)

The primary objective of this study is to further evaluate the safety and tolerability of pegaptanib sodium in subjects with DME.

A 24-month, phase IIIb, open-label, single arm, multicenter study assessing the
efficacy and safety of an individualized, stabilization criteria-driven pro re rata (PRN) dosing regimen
with 0.5-mg ranibizumab intravitreal injections applied as monotherapy in patients with visual
impairment due to macular edema secondary to central retinal vein occlusion (CRVO).

The primary objective is to evaluate the efficacy of an individualized stabilization criteriadrivenPRN dosing regimen with 0.5 mg ranibizumab as assessed by the mean best-corrected visualacuity (BCVA) change at Month 12 compared to Baseline.

A 3-year, multi-center study to evaluate optical coherencetomography as an outcome measure in patients with multiple sclerosis

Primary objective: To evaluate change in RNFL thickness in RRMS patients followed for up to 36 monthscompared to a group of reference subjects (without neurologic or ophthalmic disease) todetermine whether the technology is sufficiently sensitive to…

An open-label, multi-center, 24-month extension study to evaluate the safety of ranibizumab as symptomatic treatment for visual impairment due to diabetic macular
edema in patients who have completed the RESTORE trial

Primary objective* To evaluate ocular and non-ocular adverse events during the 24-months study period in patients treated with Lucentis (0.5 mg)Secondary objectives* To describe the ocular and non-ocular adverse events over a cumulative 36-months…

Anti-VEGF (bevacizumab/ranibizumab) versus RPE-choroid graft in the treatment of 1) non-responders to 3 intravitreal anti-VEGF injections, or 2) patients with AMD and pigment epithelium rip, or 3) patients with AMD and massive haemorrhage. A randomized trial.

To compare visual outcome and foveal function after (initiation of) treatment between patients receiving an RPE-choroid graft and patients with anti-VEGF medication.

A Phase IIIb, open-label, multi-centre, 12 month study to evaluate the safety, tolerability and efficacy of ranibizumab (0.3 mg) in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration.

The primary objective of this study is to estimate the incidence of ocular adverse events in patients with CNV secondary to AMD who receive an individualized treatment with ranibizumab 0,3 mg.

Prospective multicenter clinical trial with the PRECIZION Presbyopic multifocal intraocular lens

The main objective of this study is to evaluate the ability of the PRECIZION Presbyopia IOL to provide near, intermediate and distance vision in patients undergoing cataract extraction and intraocular lens implantation. Study outcomes will be used…

Intraocular pressure of patients with normal tension glaucoma in sitting and side-lying positions using the Goldmann applanation tonometer

The primary objective is to assess the IOP and MAP in sitting and side lying position in healthy subjects and in patients with NTG.

A MULTICENTER, OPEN-LABEL EXTENSION
STUDY TO EVALUATE THE LONG-TERM SAFETY
AND TOLERABILITY OF FARICIMAB IN PATIENTS
WITH NEOVASCULAR AGE-RELATED MACULAR
DEGENERATION

This study will evaluate the long-term safety and tolerability of IVT faricimab in patients with nAMD who have completed either of the Phase III (GR40306 or GR40844) studies. Additional assessments relating to efficacy, pharmacokinetics,…

An extension study to evaluate the long-term outcomes of subjects who received treatment for retinopathy of prematurity in Study 20090

This extension study aims to collect long-term data on safety and efficacy in a subject population treated for ROP with aflibercept and/or laser, and to contribute to the clarification of potential effects.

A 64-week, two-arm, randomized, double-masked, multicenter, phase IIIb study assessing the efficacy and safety of brolucizumab 6 mg compared to aflibercept 2 mg in a treat-to-control regimen in patients with neovascular agerelated macular degeneration (TALON)

To evaluate the efficacy and safety of brolucizumab used in a Treat-to-Control (TtC) regimen for the treatment of patients with neovascular age-related macular degeneration (nAMD) with the objective to evaluate the potential to reduce treatment…

Phase 3 Randomized, Controlled Study of AAV5-hRKp.RPGR for the Treatment of X-linked Retinitis Pigmentosa Associated with Variants in the RPGR gene

Primary:To assess the effect of bilateral treatment with AAV5-hRKp.RPGR on functional vision as measured by vision-guided mobility assessment.Secondary:To assess changes after treatment administration in retinal function, functional vision, visual…

A PHASE IIIB, MULTICENTER, RANDOMIZED,
VISUAL ASSESSOR-MASKED STUDY OF THE
EFFECTIVENESS AND SAFETY OF A 36-WEEK
REFILL REGIMEN FOR THE PORT DELIVERY
SYSTEM WITH RANIBIZUMAB VS AFLIBERCEPT
TREAT & EXTEND IN SUBJECTS WITH
NEOVASCULAR AGE-RELATED MACULAR
DEGENERATION (DIAGRID)

This study will evaluate the effectiveness and safety of a 36-week refill regimen for the PDS with ranibizumab 100 mg/mL (PDS Q36W) compared with intravitreal injections of aflibercept (2 mg) administered per a treat-and-extend regimen (aflibercept…

An Eighteen-Month, Two-Arm, Randomized, Double-Masked, Multicenter, Phase III Study assessing the Efficacy and Safety of Brolucizumab versus Aflibercept in Adult Patients with Visual Impairment due to Macular Edema secondary to Central Retinal Vein Occlusion (RAVEN)

To evaluate the efficacy and safety of brolucizumab in the treatment of patients with macular edema (ME) secondary to central retinal vein occlusion (CRVO) and its potential to reduce the treatment burden for patients.

A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of
Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects with Primary Indeterminate Lesions or Small Choroidal Melanoma

Primary: To determine the efficacy and safety of bel-sar compared to sham control for thetreatment of primary indeterminate lesions and small choroidal melanoma (IL/CM).Secondary: To assess the systemic pharmacokinetics (PK) and immunogenicity of…

A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of
Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects with Primary Indeterminate Lesions or Small Choroidal Melanoma

Primary: To determine the efficacy and safety of bel-sar compared to sham control for thetreatment of primary indeterminate lesions and small choroidal melanoma (IL/CM).Secondary: To assess the systemic pharmacokinetics (PK) and immunogenicity of…

A Long-term Follow-up Study to Evaluate the Safety and Efficacy of Retinal Gene Therapy in Subjects with Choroideremia Treated Previously with Adeno-Associated Viral Vector Encoding Rab Escort Protein-1 (AAV2-REP1) and in Subjects with X-Linked Retinitis Pigmentosa Previously Treated with Adeno-Associated Viral Vector Encoding RPGR (AAV8-RPGR) in an Antecedent Study

The objective of the study is to evaluate the long-term safety and efficacy of a sub-retinal injection of:• AAV2-REP1 in subjects with CHM who have been previously treated with AAV2-REP1 and who have exited an antecedent study; these treated…