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CompletedNCT00801541CNV-MarkersUpdated Mar 19, 2015

Characterization of Early Markers of Choroidal Neovascularization

An observational study in Age-related Macular Degeneration, sponsored by Association for Innovation and Biomedical Research on Light and Image. Completed at 1 site in Portugal. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2015-03-19.

Sponsored by Association for Innovation and Biomedical Research on Light and Image · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
50 Years and older
Sex
All
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Study summary

To this study and identify the sequence of alterations occurring in the chorioretinal interface during progression of AMD from "dry" AMD to sight-threatening chorioretinal neovascularization (CNV).

Read the detailed description

The primary statistical objective of this study is to identify the sequence of alterations occurring in the chorioretinal interface during progression of AMD from risk "dry" AMD to sight-threatening chorioretinal neovascularization (CNV) (wet AMD).

Different imaging methods will be used simultaneously and at regular intervals in order to characterize markers or predictors of conversion to sight-threatening CNV will be: CNV (classic or occult) or position of CNV within 2500 µm (\~1.7 disc diameters) of the foveal center, as evidenced by fluorescein angiography.

This is an institutional, prospective, observation study to be performed in fellow eyes of patients with evidence of "wet" AMD in other eye. Therefore, patients will have evidence of exudative ("wet") AMD in one eye ( the non-study eye) and non-exudative ("dry") AMD in the fellow eye (the study eye) that is at risk for progressive to exudation "wet" CNV.

Patients will exit the study at the time of developing sight-threatening CNV in the study eye and will be treated at the discretion of the physician.

02

Conditions studied

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In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 60 is below the median of 106 across 421 observational studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Association for Innovation and Biomedical Research on Light and Image is the lead sponsor of 38 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients of either sex, any race, aged over 50 years and over, diagnosed with exudative (wet) AMD in one eye (non-study eye) and non-exudative (dry) AMD (intermediate or large/confluent drusen, with hyperpigmentation, and no CNV or geographic atrophy) in the other eye (study eye) that is at risk for progressing to exudative (wet) AMD and meet all the inclusion and exclusion criteria.

Inclusion criteria

  • Written informed consent
  • Age over 50 years
  • Any race and any sex
  • Clinical diagnosis of exudative AM;D in one eye (non-stud eye) and the presence of the following characteristics in the second eye (study eye, eye to be treated):

    • At least 5 or more intermediate (> 63 µm) or larger soft drusen AND/OR Confluent drusen within 3000 µm of the fovea center
    • Hyperpigmentation

Exclusion criteria

Exclusion Criteria:

  • History of medical condition that would preclude scheduled study visits
  • History of ophthalmic disease in the study eye other than AMD
  • Clinical signs of myopic retinopathy, or refraction higher than -8 diopter power.
  • Intraocular surgery in the study eye within 60 days prior enrollement
  • Evidence of past or present CNV in the study eye
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • AMD

    Patients with wet AMD in one eye and dry AMD in the other eye (study eye).

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What researchers measure

Primary outcomes

  1. Wet AMD development in the study eye.

    Time frame: Single Visit

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Study locations

1 site
  • AIBILI - Clinical Trial Center
    Coimbra, 3000-548, Portugal
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References and documents

Publications

  • Marques JP, Costa M, Melo P, Oliveira CM, Pires I, Cachulo ML, Figueira J, Silva R. Ocular Risk Factors for Exudative AMD: A Novel Semiautomated Grading System. ISRN Ophthalmol. 2013 Jul 30;2013:464218. doi: 10.1155/2013/464218. eCollection 2013. PubMed 24555130 ↗

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00801541
Lead sponsor
Association for Innovation and Biomedical Research on Light and Image
Responsible party
Sponsor
First posted
Dec 3, 2008
Start date
Dec 2005
Primary completion
Dec 2008
Completion
Jun 2014
Last update
Mar 19, 2015

Study contacts

José Cunha-Vaz, MD PhD
principal investigator · Association for Innovation and Biomedical Research on Light and Image

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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