Choroidal Neovascularization Secondary to Pattern DystrophyPhase 2/3NCT00391144
Avastin for CNV Secondary to Pattern Dystrophy
A Phase 2/3 study testing intravitreal triamcinolone injection of avastin (1.25 mg) in people with Choroidal Neovascularization Secondary to Pattern Dystrophy, run by University of Trieste at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Choroidal Neovascularization Secondary to Pattern Dystrophy
- What is being tested?
- intravitreal triamcinolone injection of avastin (1.25 mg)
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2006to Oct 2006
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- conditions other than RPD
- intraocular surgery or capsulotomy within the last 2 or 1 months
- pregnancy
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Clinica Oculistica, Azienda Ospedaliero-Universitaria di Trieste
Trieste, TS, 34129
Giuseppe Ravalico, MD, +39 040 772449, giuseppe.ravalico@aots.sanita.fvg.it
About this study
Official title: 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.
Read the 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.
- Being tested
- intravitreal triamcinolone injection of avastin (1.25 mg)
- Keywords
- Pattern Dystrophy, Choroidal Neovascularization, Intravitreal Avastin Injection
- Medical subject headings
- Choroidal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravitreal triamcinolone injection of avastin (1.25 mg)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (2)
CNV progression
number of injections.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2006 (estimated)
- Study startJul 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Choroidal Neovascularization Secondary to Pattern DystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 5 participants
Sponsor and investigators
- Lead sponsor
- University of Trieste
- Sponsor type
- University, hospital or other
- Investigators
- Maurizio B Parodi, MD, Principal investigator, Clinica Oculistica, Azienda Ospedaliero-Universitaria di TriestePierluigi Iacono, MD, Principal investigator, Clinica Oculistica, Azienda Ospedaliero-Universitaria di TriesteGiuseppe Ravalico, MD, Study director, Clinica Oculistica, Azienda Ospedaliero-Universitaria di Trieste
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00391144
- Sponsor's protocol ID
- 1/2006
- Status last verified
- Oct 2006
- First submitted
- 20 Oct 2006
- Last updated
- 23 Oct 2006
- Results posted
- No
Publications
Parodi MB, Liberali T, Pedio M, Francis PJ, Piccolino FC, Fiotti N, Romano M, Ravalico G. Photodynamic therapy of subfoveal choroidal neovascularization secondary to reticular pattern dystrophy: three-year results of an uncontrolled, prospective case series. Am J Ophthalmol. 2006 Jun;141(6):1152-4. doi: 10.1016/j.ajo.2006.01.038.
PubMed 16765697Da Pozzo S, Parodi MB, Toto L, Ravalico G. Occult choroidal neovascularization in adult-onset foveomacular vitelliform dystrophy. Ophthalmologica. 2001 Nov-Dec;215(6):412-4. doi: 10.1159/000050899.
PubMed 11741106Battaglia Parodi M, Da Pozzo S, Ravalico G. Photodynamic therapy for choroidal neovascularization associated with pattern dystrophy. Retina. 2003 Apr;23(2):171-6. doi: 10.1097/00006982-200304000-00006.
PubMed 12707595Battaglia Parodi M, Di Crecchio L, Ravalico G. Vascularized pigment epithelial detachment in adult-onset foveomacular vitelliform dystrophy. Eur J Ophthalmol. 2000 Jul-Sep;10(3):266-9. doi: 10.1177/112067210001000315.
PubMed 11071039Battaglia Parodi M, Iustulin D, Russo D, Ravalico G. Adult-onset foveomacular vitelliform dystrophy and indocyanine green videoangiography. Graefes Arch Clin Exp Ophthalmol. 1996 Mar;234(3):208-11. doi: 10.1007/BF00462035.
PubMed 8720722Parodi MB, Iacono P, Cascavilla M, Zucchiatti I, Kontadakis DS, Bandello F. Intravitreal bevacizumab for subfoveal choroidal neovascularization associated with pattern dystrophy. Invest Ophthalmol Vis Sci. 2010 Sep;51(9):4358-61. doi: 10.1167/iovs.10-5237. Epub 2010 Apr 7.
PubMed 20375343
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Avastin Injection for the Treatment of Choroidal Neovascularization Secondary to Pattern Dystrophy
- ClinicalTrials.gov ID
- NCT00391144
- Acronym / sponsor ID
- 1/2006
- Keywords
- Pattern Dystrophy, Choroidal Neovascularization, Intravitreal Avastin Injection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants
- Lead sponsor
- University of TriesteUniversity, hospital or other
- Study start
- Jul 2006
- Study completion
- Oct 2006
- First posted
- 23 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- conditions other than RPD
- intraocular surgery or capsulotomy within the last 2 or 1 months
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravitreal triamcinolone injection of avastin (1.25 mg) | Procedure or surgery | – |
Primary outcome
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.
2 secondary outcomes
CNV progression
number of injections.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2006.
- Results publication: PubMed 16765697Parodi MB, Liberali T, Pedio M, Francis PJ, Piccolino FC, Fiotti N, Romano M, Ravalico G. Photodynamic therapy of subfoveal choroidal neovascularization secondary to reticular pattern dystrophy: three-year results of an uncontrolled, prospective case series. Am J Ophthalmol. 2006 Jun;141(6):1152-4. doi: 10.1016/j.ajo.2006.01.038.
- Results publication: PubMed 11741106Da Pozzo S, Parodi MB, Toto L, Ravalico G. Occult choroidal neovascularization in adult-onset foveomacular vitelliform dystrophy. Ophthalmologica. 2001 Nov-Dec;215(6):412-4. doi: 10.1159/000050899.
- Results publication: PubMed 12707595Battaglia Parodi M, Da Pozzo S, Ravalico G. Photodynamic therapy for choroidal neovascularization associated with pattern dystrophy. Retina. 2003 Apr;23(2):171-6. doi: 10.1097/00006982-200304000-00006.
- Results publication: PubMed 11071039Battaglia Parodi M, Di Crecchio L, Ravalico G. Vascularized pigment epithelial detachment in adult-onset foveomacular vitelliform dystrophy. Eur J Ophthalmol. 2000 Jul-Sep;10(3):266-9. doi: 10.1177/112067210001000315.
- Results publication: PubMed 8720722Battaglia Parodi M, Iustulin D, Russo D, Ravalico G. Adult-onset foveomacular vitelliform dystrophy and indocyanine green videoangiography. Graefes Arch Clin Exp Ophthalmol. 1996 Mar;234(3):208-11. doi: 10.1007/BF00462035.
- Derived from this study: PubMed 20375343Parodi MB, Iacono P, Cascavilla M, Zucchiatti I, Kontadakis DS, Bandello F. Intravitreal bevacizumab for subfoveal choroidal neovascularization associated with pattern dystrophy. Invest Ophthalmol Vis Sci. 2010 Sep;51(9):4358-61. doi: 10.1167/iovs.10-5237. Epub 2010 Apr 7.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maurizio B Parodi, MD principal investigator
Clinica Oculistica, Azienda Ospedaliero-Universitaria di Trieste
Pierluigi Iacono, MD principal investigator
Clinica Oculistica, Azienda Ospedaliero-Universitaria di Trieste
Giuseppe Ravalico, MD study director
Clinica Oculistica, Azienda Ospedaliero-Universitaria di Trieste
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing intravitreal triamcinolone injection of avastin (1.25 mg) in people with Choroidal Neovascularization Secondary to Pattern Dystrophy, run by University of Trieste at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maurizio B Parodi, MD (+39 040 772449, maubp@yahoo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of eyes with <15 letter loss (approximately <3 lines) at 6-month examination compared with the baseline value. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00391144, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2006.