Efficacy Study of Ranibizumab on Patients With Age-related Macular Degeneration.

NCT ID: NCT01831947

Last Updated: 2013-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2013-03-31

Brief Summary

This clinical trial investigates the impact of intravitreal injection of Ranibizumab antibody on the acuteness of vision. Patients included are suffering from choroidal neo-vascularization (CNV) as a consequence of age-related macular degeneration (AMD).

Initially, all patients get injections of 0.5 mg Ranibizumab in monthly intervals for 3 months. Subsequently, one group gets Ranibizumab in intervals of 2 months, whereas a second group is treated on demand.

The primary end point of the study is the change of best-corrected visual acuity after 12 month.

Secondary end points include the impact of Ranibizumab on morphological changes of the retina, the number of patients with gain or loss of 15 or more letters visual acuity after 12 months, changes in quality of life and the number of injections required during the first 12 months of treatment.

Conditions

Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ranibizumab fixed dose

Injection of 0.5 mg Ranibizumab every 2 months for one year, following a monthly injection during the first 3 months.

Group Type: EXPERIMENTAL

Ranibizumab

Intervention Type: BIOLOGICAL

Ranibizumab on demand

Injection of 0.5 mg Ranibizumab on demand for one year, following a monthly injection during the first 3 months.

Group Type: EXPERIMENTAL

Ranibizumab

Intervention Type: BIOLOGICAL

Interventions

Ranibizumab

Intervention Type: BIOLOGICAL

Other Intervention Names

Lucentis (Novartis Pharma)

Eligibility Criteria

Inclusion Criteria

• patients with choroidal neo-vascularization (CNV) as a consequence of age-related macular degeneration (AMD)
• age 50 and older, male and female
• membrane <= 12 papillary diameter
• visual acuity between 20/320 and 20/40 (ETDRS)
• written informed consent

Exclusion Criteria

• known hypersensitivity to the medicinal product under investigation, ingredients or medicinal products with a similar chemical structure
• participation in another clinical trial within the last 4 weeks
• unability to understand trial information
• pregnant or lactating women
• women with an amenorrhea < 12 months
• suspected unability to cooperate
• detachment of pigment epithelium without membrane detection >= 50%,retinal angiomatotic proliferation (RAP), presumed ocular histoplasmosis syndrome (POHS), chorioretinal anastomosis (CRA), myopic CNV, CNV following trauma, uveitis, RCS or reasons except AMD
• rupture of pigment epithelium
• sub-retinal bleeding >= 50% of membrane or >= 1 PD
• sub-retinal fibrosis or chorio-atrophy
• pre-treatment with Verteporfin (photodynamic therapy), radiotherapy, trans-pupillary thermotherapy of the eye under investigation as a consequence of maculadegeneration treatment with Verteporfin of the eye not under investigation within 7 days prior inclusion
• former participation in clinical trials with anti-angiogenic substances: Pegaptanib, Ranibizumab, Bevacizumab, Anecortave Acetat, Proteinkinase C Inhibitors
• former injection of anti-angiogenic substances in the eye under investigation
• former focal sub-foveal lasercoagulation of the eye under investigation
• juxta- or extra-foveal lasercoagulation of the eye under investigation within 1 month prior inclusion
• former vitrectomy
• former surgery as a consequence of maculadegeneration
• glaucoma patients which have been treated with prostaglandin containing eye drops
• other ocular diseases which may lead to surgery within the clinical study or may lead to a loss of vision of two lines
• acute intraocular inflammation of the eye under investigation
• vitreous hemorrhage of the eye under investigation
• macula-foramen of the eye under investigation
• diabetic retinopathy
• former retina detachment of the eye under investigation
• uveitis
• acute conjunctivitis, keratitis, scleritis, or endophthalmitis
• aphakia or pseudo-aphakia with damaged back-capsule(exception: YAG-capsulotomy)
• myopia larger than -8 diopter
• former intra-ocular surgery of the eye under investigation within 2 months prior inclusion
• de-compensated glaucoma with >= 30 mm Hg despite therapy
• former filtrating glaucoma surgery of the eye under investigation
• former corneal grafting of the eye under investigation
• former stroke or heart attack
• on-going therapy because of systemic infection
• known allergic reaction to fluorescein
• bad quality of fundus documentation because of bad range of vision

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

University Medical Center Goettingen

OTHER

Sponsor Role: collaborator

Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dept. of Ophthalmology, University Medical Center Goettingen

Göttingen, , Germany

Countries

Germany

Other Identifiers

CRFB002ADE09T

Identifier Type: -

Identifier Source: org_study_id