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Avastin for CNV Secondary to Pattern Dystrophy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by University of Trieste.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Trieste
ClinicalTrials.gov Identifier:
NCT00391144
First received: October 20, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted

October 20, 2006
October 20, 2006
July 2006
Not Provided
  • number of eyes with <15 letter loss (approximately <3 lines) at 6-month examination compared with the baseline value
  • numeber of eyes with <15 letter loss at 12-month examinations, compared with the baseline value.
Same as current
No Changes Posted
  • CNV progression
  • number of injections.
Same as current
Not Provided
Not Provided
 
Avastin for CNV Secondary to Pattern Dystrophy
Intravitreal Avastin Injection for the Treatment of Choroidal Neovascularization Secondary to Pattern Dystrophy

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.

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.
Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Choroidal Neovascularization Secondary to Pattern Dystrophy
Procedure: intravitreal triamcinolone injection of avastin (1.25 mg)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5
October 2006
Not Provided

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
Both
20 Years to 80 Years
No
Contact: Maurizio B Parodi, MD +39 040 772449 maubp@yahoo.it
Contact: Giuseppe Ravalico, MD +39 040 772449 giuseppe.ravalico@aots.sanita.fvg.it
Italy
 
NCT00391144
1/2006
Not Provided
Not Provided
University of Trieste
Not Provided
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
University of Trieste
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP