Clinical trial NCT01831947: Efficacy Study of Ranibizumab on Patients With Age-related Macular Degeneration.
Official title: Efficacy of Ranibizumab Treatment Every 2 Month Compared to Treatment on Demand on Patients With Choroidal Neo-vascularization (CNV) as a Consequence of Age-related Macular Degeneration (AMD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Macular Degeneration
Keywords: age-related macular degeneration
Ranibizumab
Lead sponsor: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
name: University Medical Center Goettingen
First posted: 2013-04-15
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: best-corrected visual acuity
timeFrame: 12 months after start of treatment
Secondary outcomes:
measure: Fluoresceinangiography
timeFrame: 12 months after start of treatment
measure: Photography
timeFrame: 12 months after treatment start
measure: optical coherence tomography (OCT)
timeFrame: 12 months after treatment start
measure: number of injections
timeFrame: 12 months after treatment start
measure: quality of life
timeFrame: 12 months after treatment start
Other outcomes:
Locations:
city: Goettingen
country: Germany
facility: Dept. of Ophthalmology, University Medical Center Goettingen
Study officials:
References: