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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…

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 macular edema (ME) (CRFB002G2302)

Primary: To demonstrate that intravitreal injection of 0.5 mg ranibizumab administered based on individual patient needs has superior efficacy compared to sham treatment in adult patients with visual impairment due to VEGF-driven ME. Secondary: Best…

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.

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.

A randomized, double-masked, multicenter, laser-controlled Phase III study assessing the efficacy and safety of ranibizumab (intravitreal injections) as adjunctive and mono-therapy in patients with visual impairment due to diabetic macular edema

Primary objectiveto demonstrate superiority of ranibizumab 0.5 mg as adjunctive or mono-therapy to laser treatment in the mean change from baseline in BCVA over a 12-month treatment period.Secondary objectives* to evaluate whether ranibizumab (0.5…

A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-MASKED, ACTIVE COMPARATOR-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FARICIMAB IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION (TENAYA)

The purpose of this study is to investigate the efficacy, safety, durability, and pharmacokinetics of faricimab administered at up to 16-week intervals to treatment-naive patients with nAMD.

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 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…

A Two-Year, 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 Diabetic Macular Edema

In this study we want to find out how safe and effective is the new product brolucizumab. Brolucizumab is administered in this study to subjects with decreased sight due to diabetes macular edema. The effects of brolucizumab are compared with those…

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…

Pred Forte® in chronic central serous chorioretinopathy

This study has been transitioned to CTIS with ID 2024-511575-15-00 check the CTIS register for the current data. The main objective is the measure the effect on subretinal and intraretinal fluid in severe cCSC calculated by the cumulative areas of…

Open-label, randomized, two*arm, controlled study to assess the efficacy, safety, and tolerability of intravitreal (IVT) aflibercept compared to laser photocoagulation in patients with retinopathy of prematurity (ROP)

The purpose of this study is to confirm how well aflibercept works in babies with ROP, comparing it with laser therapy. The study also has the objective to demonstrate how safe aflibercept is when used in babies. We will also learn how the drug…

A Randomised, Open Label, Outcomes-Assessor Masked, Prospective, Parallel Controlled Group, Phase 3 Clinical Trial Of Retinal Gene Therapy For Choroideremia Using An Adeno-Associated Viral Vector (AAV2) Encoding Rab Escort Protein 1 (REP1)

The objective of the study is to evaluate the efficacy and safety of a single sub-retinal injection of AAV2-REP1 in subjects with choroideremia (CHM).

Early treatment of central serous retinopathy by photodynamic therapy. A randomized controlled trial.

To determine the outcome in CSR patients comparing treatment with PDT versus observation.