ClinicalTrials.gov
ClinicalTrials.gov Menu

Posterior Macular Adhesion: A Potential Risk Factor for Non-exudative Age Related Macular Degeneration (AMD) to Develop Exudative AMD (PAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00926861
Recruitment Status : Unknown
Verified June 2010 by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery.
Recruitment status was:  Recruiting
First Posted : June 24, 2009
Last Update Posted : June 9, 2010
Sponsor:
Information provided by:
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Brief Summary:
Choroidal neovascularisation in age related macular degeneration is one of the major causes of legal blindness in the western world existing in two major occurences, the dry and the wet form.The etiology of age related macular degeneration is yet unknown. Genetic factors, oxidative stress, Ischaemia, and aging of the retinal pigment epithelium are discussed as etiologic factors. The risk of rapid vision loss is much higher in wet AMD, a dry form may transform to a wet form. From a prior study the investigators know that the posterior hyaloid is significantly more frequent attached in wet AMD. This study is conducted to examine whether the attached posterior hyaloid is a risk factor to develop wet AMD in dry AMD cases.

Condition or disease Intervention/treatment
Dry Age-related Macular Degeneration Detachment of the Posterior Hyaloid Device: ultrasound Device: OCT

Study Type : Observational
Estimated Enrollment : 320 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Posterior Macular Adhesion: A Potential Risk Factor for Non-exudative AMD to Develop Exudative AMD
Study Start Date : July 2009
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Dry AMD
male or female persons aged over 50 years with dry age-related macular degeneration
Device: ultrasound
A-scan and B-scan ultrasound at baseline and month 6,12,24
Device: OCT
Volume scans of spectralis OCT at baseline and month 6,12,24



Primary Outcome Measures :
  1. Number of eyes with non-exudative AMD with attached and detached posterior vitreous cortex developing exudative AMD [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Distance acuity [ Time Frame: 24 months ]
  2. Age [ Time Frame: 24 months ]
  3. Smoking [ Time Frame: 24 months ]
  4. Obesity [ Time Frame: 24 months ]
  5. Lesion classification (AREDS) [ Time Frame: 24 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
male or female persons aged over 50 years with dry AMD
Criteria

Inclusion Criteria:

  • Dry MD
  • Age over 50 years

Exclusion Criteria:

  • Macular pathologies other than age related macular degeneration (like diabetic maculopathy, macular pucker, macular hole)
  • Prior vitrectomy or buckle surgery
  • Uveitis posterior, multifocal chorioiditis
  • Pathologic myopia
  • Diabetic retinopathy
  • Visualization of the macula not possible (dens cataract, vitreous haemorrhage)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00926861


Contacts
Contact: Ilse Krebs, MD +43171165 ext 4607 ilse.krebs@wienkav.at

Locations
Austria
Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery Recruiting
Vienna, Austria, 1030
Contact: Ilse Krebs, MD    43-17-1165 ext 94682    Ilse.Krebs@wienkav.at   
Sub-Investigator: Ilse Krebs, MD         
Sponsors and Collaborators
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Investigators
Study Chair: Susanne Binder, Prof MD Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery

Responsible Party: Ilse Krebs,MD, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier: NCT00926861     History of Changes
Other Study ID Numbers: 09-052-0409
First Posted: June 24, 2009    Key Record Dates
Last Update Posted: June 9, 2010
Last Verified: June 2010

Keywords provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:
age-related macular degeneration
detachment of the posterior hyaloid
AMD

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases