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Macular DegenerationPhase 4RABIMONCT01831947

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

A Phase 4 study testing Ranibizumab in people with Macular Degeneration, run by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Macular Degeneration
What is being tested?
Ranibizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteGermany
Study dates
Apr 2010to Mar 2013
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 36Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Dept. of Ophthalmology, University Medical Center Goettingen

    Göttingen, 37075

Other trials in Germany

About this study

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)

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.

Read more

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.

Being tested
Ranibizumab
Keywords
age-related macular degeneration, Ranibizumab
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RanibizumabBiological

    Also called Lucentis (Novartis Pharma)

Study groups in NCT01831947
Study groupRoleWhat they receive
Ranibizumab fixed doseExperimentalInjection of 0.5 mg Ranibizumab every 2 months for one year, following a monthly injection during the first 3 months.
Receives: Biological: Ranibizumab
Ranibizumab on demandExperimentalInjection of 0.5 mg Ranibizumab on demand for one year, following a monthly injection during the first 3 months.
Receives: Biological: Ranibizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. best-corrected visual acuity

    Change of best-corrected visual acuity before and 12 months after start of treatment with respect to number of letters read on ETDRS-sheets (Early Treatment Diabetes Retinopathy Study Sheets).

    Measured: 12 months after start of treatment

Secondary outcomes (5)

  1. Fluoresceinangiography

    To study morphological and anatomical changes of the retina. Affected area is determined in mm²

    Measured: 12 months after start of treatment

  2. Photography

    To study morphological and anatomical changes of the retina. Affected area is assessed by computer-assisted measurement in mm².

    Measured: 12 months after treatment start

  3. optical coherence tomography (OCT)

    To study morphological and anatomical changes of the retina. Thickness of the retina is determined in µm².

    Measured: 12 months after treatment start

  4. number of injections

    Measured: 12 months after treatment start

  5. quality of life

    change in quality of life

    Measured: 12 months after treatment start

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2013 (estimated)
  2. Study startApr 2010
  3. Primary completionMar 2013
  4. Study completionMar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01831947
Sponsor's protocol ID
CRFB002ADE09T
Acronym
RABIMO
Status last verified
Apr 2013
First submitted
11 Apr 2013
Last updated
15 Apr 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ranibizumab in people with Macular Degeneration, run by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

best-corrected visual acuity (time frame: 12 months after start of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01831947.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2013.

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