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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Intravitreal Avastin Injection for the Treatment of Choroidal Neovascularization Secondary to Pattern Dystrophy

Resource links provided by NLM:


Further study details as provided by University of Trieste:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • CNV progression
  • number of injections.

Estimated Enrollment: 5
Study Start Date: July 2006
Estimated Study Completion Date: October 2006
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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Additional 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
Study First Received: October 20, 2006
Last Updated: October 20, 2006
Health Authority: Italy: National Institute of Health

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

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

ClinicalTrials.gov processed this record on April 15, 2014