Advertisement

Topics

A Safety and Efficacy Study of E10030 (Anti-PDGF Pegylated Aptamer) Plus Lucentis for Neovascular Age-Related Macular Degeneration

2014-07-23 21:09:47 | BioPortfolio

Summary

The objectives of this study are to evaluate the safety and efficacy of E10030 intravitreous injection when administered in combination with Lucentis® against a control of Lucentis® alone in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).

Description

Subjects will be randomized in a 1:1:1 ratio to the following dose groups:

- E10030 0.3 mg/eye + Lucentis® 0. 5 mg/eye

- E10030 1.5 mg/eye + Lucentis® 0. 5 mg/eye

- E10030 sham + Lucentis® 0. 5 mg/eye

Subjects will be treated with active E10030 or sham E10030 in combination with Lucentis® at Day 0, Week 4, Week 8, Week 12, Week 16 and Week 20.

Primary Efficacy Endpoint:

The primary efficacy endpoint is the proportion of subjects gaining at least 15 letters between baseline and the Week 12 visit.

Safety Endpoints:

Safety endpoints include adverse events, vital signs, ophthalmic variables [visual acuity, intraocular pressure (IOP), ophthalmic examination, color fundus photography, fluorescein angiograms (FA), optical coherence tomography (OCT)], and laboratory variables.

Approximately 444 subjects will be randomized into one of the three treatment cohorts (approximately 148 patients per dose group).

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Age-Related Macular Degeneration

Intervention

E10030 plus Lucentis, Lucentis

Location

Retinal Consultants
Slingerlands
New York
United States
12159

Status

Recruiting

Source

Ophthotech Corporation

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:09:47-0400

Clinical Trials [882 Associated Clinical Trials listed on BioPortfolio]

A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® Monotherapy

The objectives of this study are to evaluate the safety and efficacy of intravitreal administration of Fovista® administered in combination with Lucentis® compared to Lucentis® monother...

A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® Monotherapy

The objectives of this study are to evaluate the safety and efficacy of intravitreal administration of Fovista® administered in combination with Lucentis® compared to Lucentis® monother...

A Phase 1, Safety, Tolerability and Pharmacokinetic Profile of Intravitreous Injections of E10030 (Anti-PDGF Pegylated Aptamer) in Subjects With Neovascular Age-Related Macular Degeneration

The objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic profile of E10030 intravitreous injection when administered as monotherapy or in combination wit...

Study Assessing the Efficacy and Safety of Intravitreal Injections of DE-122 in Combination With Lucentis® Compared to Lucentis® Monotherapy in Wet Age-related Macular Degeneration Subjects

To assess the safety and efficacy of repeated intravitreal injections of DE-122 (low dose and high dose) given in combination with Lucentis® in subjects with wet age-related macular degen...

Prospective OCT Study With Lucentis for Neovascular AMD (PrONTO Study)

The PrONTO Study was designed to evaluate the response of neovascular age-related macular degeneration (AMD) patients to intravitreal Lucentis using Optical Coherence Tomography (OCT) imag...

PubMed Articles [10140 Associated PubMed Articles listed on BioPortfolio]

Frequency of Bevacizumab and Ranibizumab Injections for Diabetic Macular Edema in Medicare Beneficiaries.

To describe the frequency and variation of intravitreal bevacizumab (Avastin; Genentech, South San Francisco, CA) and ranibizumab (Lucentis; Genentech, South San Francisco, CA) use for diabetic macula...

Intake of vegetables, fruit, and fish is beneficial for Age-related Macular Degeneration.

What patients should eat to reduce their risk of age-related macular degeneration (AMD) is still unclear. We investigated the effect of a diet recommended by Health Councils on AMD.

OCT Angiography Helps Distinguish Between Proliferative Macular Telangiectasia Type 2 and Neovascular Age-Related Macular Degeneration.

To demonstrate the advantage of optical coherence tomography angiography (OCTA) for the diagnosis and management of proliferative macular telangiectasia type 2 (MacTel2) masquerading as neovascular ag...

Impact of Choriocapillaris Flow on Multifocal Electroretinography in Intermediate Age-Related Macular Degeneration Eyes.

To investigate the relationship between perfusion of the choriocapillaris (CC) and macular function in eyes with intermediate age-related macular degeneration.

Incidence of and Risk Factors Associated With Age-Related Macular Degeneration: Four-Year Follow-up From the ALIENOR Study.

While the prevalence of age-related macular degeneration (AMD) differs according to continents and races/ethnicities, its incidence in the European continent has been scarcely documented.

Medical and Biotech [MESH] Definitions

A form of MACULAR DEGENERATION also known as dry macular degeneration marked by occurrence of a well-defined progressive lesion or atrophy in the central part of the RETINA called the MACULA LUTEA. It is distinguishable from WET MACULAR DEGENERATION in that the latter involves neovascular exudates.

Specialized ophthalmic technique used in the surgical repair and or treatment of disorders that include retinal tears or detachment; MACULAR HOLES; hereditary retinal disease; AIDS-related retinal infections; ocular tumors; MACULAR DEGENERATION; DIABETIC RETINOPATHY; and UVEITIS.

A retrogressive pathological change in the retina, focal or generalized, caused by genetic defects, inflammation, trauma, vascular disease, or aging. Degeneration affecting predominantly the macula lutea of the retina is MACULAR DEGENERATION. (Newell, Ophthalmology: Principles and Concepts, 7th ed, p304)

A recombinant humanized monoclonal antibody fragment that binds VEGF-A to prevent its binding to VEGFR-1 and VEGFR-2 receptors. This activity reduces vessel permeability and angiogenesis in the treatment of neovascular age-related MACULAR DEGENERATION.

A form of RETINAL DEGENERATION in which abnormal CHOROIDAL NEOVASCULARIZATION occurs under the RETINA and MACULA LUTEA, causing bleeding and leaking of fluid. This leads to bulging and or lifting of the macula and the distortion or destruction of central vision.

More From BioPortfolio on "A Safety and Efficacy Study of E10030 (Anti-PDGF Pegylated Aptamer) Plus Lucentis for Neovascular Age-Related Macular Degeneration"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Ophthalmology
Ophthalmology is the branch of medicine that is devoted to the study and treatment of eye diseases. As well as mild visual defects correctable by lenses, ophthalmology is concerned with glaucoma, uveitis and other serious conditions affecting the eye, ...


Searches Linking to this Trial