NCT00510965

Brief Summary

The purpose of the study is to investigate the efficacy of a new drug called ranibizumab in the treatment of choroidal neovascularization in underlying angioid streaks due to Pseudoxanthoma elasticum. 10 patients will receive monthly injections of the drug in one eye over a period of one year.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2007

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2007

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2007

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

June 15, 2012

Status Verified

August 1, 2011

Enrollment Period

2.7 years

First QC Date

August 1, 2007

Last Update Submit

June 14, 2012

Conditions

Choroidal Neovascularization

Keywords

choroidal neovascularizationangioid streakspseudoxanthoma elasticumGroenblad-Strandberg-SyndrometherapyranibizumablucentisChoroidal neovascularization in patients with PXE

Outcome Measures

Primary Outcomes (1)

  • Best corrected visual acuity

    one year

Secondary Outcomes (4)

  • Reading ability

    one year

  • Changes in retinal thickness assessed by optical coherence tomography

    one year

  • Changes in parafoveal leakage assessed by fluorescein angiography

    one year

  • Quality of life

    one year

Study Arms (1)

A

EXPERIMENTAL
Drug: Intravitreal injection ranibizumab

Interventions

Intravitreal injection ranibizumabDRUG

Monthly intravitreal injection of 0.5mg ranibizumab in one eye over one year

Also known as: Lucentis
A

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of choroidal neovascularization in patients with pseudoxanthoma elasticum
  • Age between 18-65 years
  • Patient must be able to follow protocol
  • Written informed consent
  • Genetic diagnosis of pseudoxanthoma elasticum
  • Best corrected visual acuity between 20/200 - 20/32 in the treated eye

You may not qualify if:

  • Patients with other retinal vascular diseases such as diabetic retinopathy or venous occlusive disease
  • Ocular surgery 3 months before study enrollment
  • History of uncontrolled glaucoma
  • Active intraocular inflammation or inflammation of the ocular adnexa
  • Subfoveal fibrosis in the study eye
  • Inability to follow study protocol
  • Major surgery one month before study enrollment
  • History of severe cardiovascular disease or history of stroke 6 months before study enrollment
  • Allergies against the substances or components of the study medication
  • Low anticipated compliance
  • Patients who participated in clinical trials simultaneously or within the last 60 days
  • Pregnancy, lactation, women that may become pregnant and don't use safe contraception
  • Chronic alcohol- or drug abuse within the last year
  • Lacking legal competence or language ability
  • Neurologic diseases such as multiple sclerosis
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bonn

Bonn, 53127, Germany

Location

Related Publications (1)

  • Finger RP, Charbel Issa P, Hendig D, Scholl HP, Holz FG. Monthly ranibizumab for choroidal neovascularizations secondary to angioid streaks in pseudoxanthoma elasticum: a one-year prospective study. Am J Ophthalmol. 2011 Oct;152(4):695-703. doi: 10.1016/j.ajo.2011.03.022. Epub 2011 Jun 25.

    PMID: 21704964DERIVED

Related Links

MeSH Terms

Conditions

Choroidal NeovascularizationAngioid StreaksPseudoxanthoma Elasticum

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Choroid DiseasesUveal DiseasesEye DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and SymptomsRetinal DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic DiseasesSkin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticGenetic Diseases, InbornConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Frank G. Holz, MD

    University of Bonn, Department of Ophthalmology

    PRINCIPAL INVESTIGATOR

  • Hendrik PN Scholl, MD, MA

    University of Bonn

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 1, 2007

First Posted

August 3, 2007

Study Start

August 1, 2007

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

June 15, 2012

Record last verified: 2011-08

Locations

DE(1)