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Avastin for CNV Secondary to Pattern Dystrophy

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ClinicalTrials.gov Identifier: NCT00391144
Recruitment Status : Unknown
Verified October 2006 by University of Trieste.
Recruitment status was:  Recruiting
First Posted : October 23, 2006
Last Update Posted : October 23, 2006
Sponsor:
Information provided by:
University of Trieste

Brief Summary:

The natural history of subfoveal CNV secondary to Pattern Dystrophy is little understood, but it seems that visual function may be preserved only in the short-term follow-up, with progressive deterioration thereafter.

Photodynamic therapy with verteporfin is the most studied therapeuthic option for this kindf of lesion, but unfortunately, this approach does not appear to guarantee long-term vision stabilization, and alternative therapies should be investigated.


Condition or disease Intervention/treatment Phase
Choroidal Neovascularization Secondary to Pattern Dystrophy Procedure: intravitreal triamcinolone injection of avastin (1.25 mg) Phase 2 Phase 3

Detailed Description:

Diagnosis of Pattern Dystrophy Diagnosis of subfoveal CNV Intravitreal injection of avastin (1.25 mg) in operating room under sterile condition.

Retreatment on the basis of the detection of disease progression and of lack of central retinal thickness reduction on OCT.


Study Type : Interventional  (Clinical Trial)
Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Intravitreal Avastin Injection for the Treatment of Choroidal Neovascularization Secondary to Pattern Dystrophy
Study Start Date : July 2006
Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. number of eyes with <15 letter loss (approximately <3 lines) at 6-month examination compared with the baseline value
  2. numeber of eyes with <15 letter loss at 12-month examinations, compared with the baseline value.

Secondary Outcome Measures :
  1. CNV progression
  2. number of injections.


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of RPD (hyperpigmented yellowish-greyish network, other family members sharing RPD, normal electroretinogram and normal/subnormal electrooculogram)
  • classic or occult CNV involving the foveal avascular zone’s geometric centre

Exclusion Criteria:

  • conditions other than RPD
  • intraocular surgery or capsulotomy within the last 2 or 1 months
  • pregnancy

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): NCT00391144


Contacts
Contact: Maurizio B Parodi, MD +39 040 772449 maubp@yahoo.it
Contact: Giuseppe Ravalico, MD +39 040 772449 giuseppe.ravalico@aots.sanita.fvg.it

Locations
Italy
Clinica Oculistica, Azienda Ospedaliero-Universitaria di Trieste Recruiting
Trieste, TS, Italy, 34129
Contact: Giuseppe Ravalico, MD    +39 040 772449    giuseppe.ravalico@aots.sanita.fvg.it   
Sponsors and Collaborators
University of Trieste
Investigators
Principal Investigator: Maurizio B Parodi, MD Clinica Oculistica, Azienda Ospedaliero-Universitaria di Trieste
Principal Investigator: Pierluigi Iacono, MD Clinica Oculistica, Azienda Ospedaliero-Universitaria di Trieste
Study Director: Giuseppe Ravalico, MD Clinica Oculistica, Azienda Ospedaliero-Universitaria di Trieste

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00391144     History of Changes
Other Study ID Numbers: 1/2006
First Posted: October 23, 2006    Key Record Dates
Last Update Posted: October 23, 2006
Last Verified: October 2006

Keywords provided by University of Trieste:
Pattern Dystrophy
Choroidal Neovascularization
Intravitreal Avastin Injection

Additional relevant MeSH terms:
Neoplasm Metastasis
Neovascularization, Pathologic
Choroidal Neovascularization
Neoplastic Processes
Neoplasms
Pathologic Processes
Metaplasia
Choroid Diseases
Uveal Diseases
Eye Diseases
Bevacizumab
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action