NCT01831947

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2010

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 11, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 15, 2013

Completed
Last Updated

April 15, 2013

Status Verified

April 1, 2013

Enrollment Period

2.9 years

First QC Date

April 11, 2013

Last Update Submit

April 11, 2013

Conditions

Macular Degeneration

Keywords

age-related macular degenerationRanibizumab

Outcome Measures

Primary Outcomes (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).

    12 months after start of treatment

Secondary Outcomes (5)

  • Fluoresceinangiography

    12 months after start of treatment

  • Photography

    12 months after treatment start

  • optical coherence tomography (OCT)

    12 months after treatment start

  • number of injections

    12 months after treatment start

  • quality of life

    12 months after treatment start

Study Arms (2)

Ranibizumab fixed dose

EXPERIMENTAL

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

Biological: Ranibizumab

Ranibizumab on demand

EXPERIMENTAL

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

Biological: Ranibizumab

Interventions

RanibizumabBIOLOGICAL
Also known as: Lucentis (Novartis Pharma)
Ranibizumab fixed doseRanibizumab on demand

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • former vitrectomy
  • former surgery as a consequence of maculadegeneration
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Ophthalmology, University Medical Center Goettingen

Göttingen, 37075, Germany

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2013

First Posted

April 15, 2013

Study Start

April 1, 2010

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

April 15, 2013

Record last verified: 2013-04

Locations

DE(1)