Eye Diseases

All Conditions

Neoplasms

Symptoms and General Pathology

Heart and Blood Diseases

Macular Edema

Neoplasm Metastasis

Edema

Retinal Vein Occlusion

Neoplastic Processes

Macular Degeneration

Retinal Degeneration

Retinal Diseases

Thrombosis

Venous Thrombosis

Embolism

Embolism and Thrombosis

Vascular Diseases

Antineoplastic Agents

All Drugs and Chemicals

Aflibercept

Endothelial Growth Factors

Mitogens

Angiogenesis Inhibitors

Growth Inhibitors

Monthly IVT injection of VEGF Trap-Eye 2.0 mg until Week 24 Primary Endpoint

Monthly Sham IVT injection until Week 24 Primary Endpoint

Monthly intravitreal injection out to the Week 24 Primary endpoint

VEGF Trap-Eye 2.0mg

Monthly sham intravitreal injection out to Week 24 Primary Endpoint

Sham

Clinical Trial Management

This is a phase 3 study to determine the efficacy of VEGF Trap-Eye injected into the eye on vision function in subjects with macular edema as a consequence of central retinal vein occlusion.

Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO)

A Randomized, Double Masked, Controlled Phase 3 Study of the Efficacy, Safety, and Tolerability of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor Trap-Eye in Subjects With Macular Edema Secondary to Central Retinal Vein Occlusion

Percentage values indicate the number of subjects in each arm who were able to read an additional 15 letters or more at Week 24 compared to baseline.

Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 24 letters (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.

Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.

The NEI VFQ-25 assesses visual function and quality of life. Total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight.

Bayer

Regeneron Pharmaceuticals

Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period.

Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 20. Participants were observed until Week 24.

Participants in the safety population were at risk.

Intravitreal Aflibercept Injection (IAI) (Baseline to Week 24)

Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 20. Participants were observed until Week 24. Participants in the safety population were at risk.

Sham Treatment (Baseline to Week 24)

Starting at week 24 through week 52, participants were evaluated monthly to receive either the 2 mg Intravitreal Aflibercept Injection (IAI) PRN or sham injection according to the protocol re-treatment criteria as assessed by the masked physician. If none of the re-treatment criteria were met, participants received a sham injection.

From Week 52 to 100, participants were evaluated every three months, but could receive injections of IAI up to monthly if re-treatment criteria were met; sham injections were not given. Participants were observed from Week 24 to Week 100. Participants in the safety population that completed Week 24 were at risk.

IAI to IAI (Week 24 to Week 100)

Starting at week 24 through week 52, participants were eligible for active treatment and were evaluated monthly to receive either 2 mg Intravitreal Aflibercept Injection (IAI) PRN or sham injection according to the protocol re-treatment criteria as assessed by the masked physician.

From Week 52 to 100, participants were evaluated every three months, but could receive injections of IAI up to monthly if re-treatment criteria were met; sham injections were not given.

Sham Treatment to IAI (Week 24 to Week 100)

Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.

Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)

Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.

Sham Treatment

Total

Age Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Baseline Retinal Thickness by Optical Coherence Tomography (OCT)

The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight.

Baseline National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score

Baseline Intraocular Pressure

Perfused

Non-Perfused

Indeterminate

Retinal Perfusion defined as less than 10 disc areas of capillary non-perfusion using fluorescein angiography (FA).

Non-Perfused defined as greater than or equal to 10 disc areas of non-perfusion.

Indeterminate defined as not able to be determined by the reading center; for the purposes of analysis, indeterminate patients were considered non-perfused.

Number of Participants with Retinal Perfusion at Baseline

Only participants with an ETDRS (Early Treatment Diabetic Retinopathy Study) Best Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye at 4 meters were included; a higher score represents better functioning.

Baseline Best Corrected Visual Acuity (BCVA) Letter Score

</= 2 Months

> 2 Months

Missing

Time Since Central Retinal Vein Occlusion (CRVO) Diagnosis

Clinical Trials Administrator

Percentage of Participants Who Gained at Least 15 Letters in BCVA at Week 24 as Measured by ETDRS Letter Score

Change From Baseline in BCVA as Measured by ETDRS Letter Score at Week 24 - Last Observation Carried Forward (LOCF)

Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF

Any neovascularization

Anterior segment neovascularization

Neovascularization of the optic disc (NVD)

Neovascularization elsewhere in the fundus (NVE)

Percentage of Participants Progressing to Any of the Following: Anterior Segment Neovascularization, New Vessels of the Disc (NVD) or New Vessels Elsewhere (NVE) During the First 24 Weeks

Change From Baseline in the NEI VFQ-25 in Total Score at Week 24 (LOCF)

Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.

Starting at week 24 through week 52, participants were evaluated monthly to receive either the 2 mg IAI PRN or sham injection according to the protocol re-treatment criteria as assessed by the masked physician. If none of the re-treatment criteria were met, participants received a sham injection.

From Week 52 to 100, participants were evaluated every three months, but could receive injections of IAI up to monthly if re-treatment criteria were met; sham injections were not given. Participants were observed from Week 24 to Week 100. Participants in the safety population that completed Week 24 were at risk.

Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.

Starting at week 24 through week 52, participants were eligible for active treatment and were evaluated monthly to receive either 2 mg IAI PRN or sham injection according to the protocol re-treatment criteria as assessed by the masked physician.

From Week 52 to 100, participants were evaluated every three months, but could receive injections of IAI up to monthly if re-treatment criteria were met; sham injections were not given.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO)	NCT00943072	Macular Edema S...	VEGF Trap-Eye 2... Sham	18 Years -	Regeneron Pharmaceuticals
Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO)	NCT00943072	Macular Edema S...	VEGF Trap-Eye 2... Sham	18 Years -	Regeneron Pharmaceuticals

Spots Global Cancer Trial Database for copernicus

Every month we try and update this database with for copernicus cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for copernicus

Every month we try and update this database with for copernicus cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for copernicus cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.