Choroidal NeovascularizationPhase 2NCT00510965
Ranibizumab to Treat Choroidal Neovascularization (CNV) in Patients With Pseudoxanthoma Elasticum (PXE)
A Phase 2 study testing Intravitreal injection ranibizumab in people with Choroidal Neovascularization, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
The purpose of the study is to investigate the efficacy of a new drug called ranibizumab in the treatment of choroidal neovascularization in underlying angioid streaks due to Pseudoxanthoma elasticum. 10 patients will receive monthly injections of the drug in one eye over a period of one year. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Choroidal Neovascularization
- What is being tested?
- Intravitreal injection ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2007to Apr 2010
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of choroidal neovascularization in patients with pseudoxanthoma elasticum
- Age between 18-65 years
- Patient must be able to follow protocol
- Written informed consent
- Genetic diagnosis of pseudoxanthoma elasticum
- Best corrected visual acuity between 20/200 - 20/32 in the treated eye
Who cannot join
- Patients who do not fulfill the inclusion criteria
- Patients with other retinal vascular diseases such as diabetic retinopathy or venous occlusive disease
- Ocular surgery 3 months before study enrollment
- History of uncontrolled glaucoma
- Active intraocular inflammation or inflammation of the ocular adnexa
- Subfoveal fibrosis in the study eye
Show all 18Show fewer
- Inability to follow study protocol
- Major surgery one month before study enrollment
- History of severe cardiovascular disease or history of stroke 6 months before study enrollment
- Allergies against the substances or components of the study medication
- Low anticipated compliance
- Patients who participated in clinical trials simultaneously or within the last 60 days
- Pregnancy, lactation, women that may become pregnant and don't use safe contraception
- Chronic alcohol- or drug abuse within the last year
- Lacking legal competence or language ability
- Neurologic diseases such as multiple sclerosis
- Need of concomitant medication that is not allowed in combination with ranibizumab
- Previous intravitreal therapy with anti-angiogenic substances in the study eye within the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ranibizumab in Choroidal Neovascularization (CNV) Due to Pseudoxanthoma Elasticum (PXE, Groenblad-Strandberg-Syndrome)
The purpose of the study is to investigate the efficacy of a new drug called ranibizumab in the treatment of choroidal neovascularization in underlying angioid streaks due to Pseudoxanthoma elasticum. 10 patients will receive monthly injections of the drug in one eye over a period of one year.
Read the detailed description
Pseudoxanthoma elasticum (PXE) is a rare hereditary systemic disease affecting mainly the skin, eyes and the cardiovascular system. Commonly, complicating choroidal neovascularization (CNV) of the central retina lead to a severely decreased visual acuity in the course of the disease. Onset of the symptoms varies with the extend of the PXE-associated findings.
In the past there has been no effective treatment for the disease's ocular complications. Recent studies in a limited number of patients with CNV treated with intravitreal injections of bevacizumab, an antagonist targeting vascular endothelial growth factor (VEGF), have shown a preservation of function and regression of CNV. An increase of visual acuity was reported in a subset of patients. Bevacizumab is a humanized antibody of which ranibizumab is a fragment.
This trial is initiated in order to investigate the effect of ranibizumab on functional outcome measures such as preservation of visual acuity as well as morphological outcome measures such as regression of CNV in angiography.
The safety and tolerability of ranibizumab will be investigated as well. As it has been tested on large numbers of patients suffering from age-related macular degeneration with only rare significant side effects or adverse events being reported, a good safety profile is assumed.
The study is conducted in a non-randomized, uncontrolled prospective setting at one center.
Patients will receive monthly injections over a period of one year.
- Conditions
- Choroidal Neovascularization
- Being tested
- Intravitreal injection ranibizumab
- Keywords
- choroidal neovascularization, angioid streaks, pseudoxanthoma elasticum, Groenblad-Strandberg-Syndrome, therapy, ranibizumab, lucentis, Choroidal neovascularization in patients with PXE
- Medical subject headings
- Choroidal Neovascularization, Angioid Streaks, Pseudoxanthoma Elasticum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal injection ranibizumabDrug
Also called Lucentis
Monthly intravitreal injection of 0.5mg ranibizumab in one eye over one year
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Intravitreal injection ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity
Measured: one year
Secondary outcomes (4)
Reading ability
Measured: one year
Changes in retinal thickness assessed by optical coherence tomography
Measured: one year
Changes in parafoveal leakage assessed by fluorescein angiography
Measured: one year
Quality of life
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Choroidal NeovascularizationStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Investigators
- Frank G. Holz, MD, Principal investigator, University of Bonn, Department of OphthalmologyHendrik PN Scholl, MD, MA, Principal investigator, University of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00510965
- Sponsor's protocol ID
- CRFB002ADE03
- Other IDs
- EudraCT number 2006-006233-49
- Status last verified
- Aug 2011
- First submitted
- 1 Aug 2007
- Last updated
- 15 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Finger RP, Charbel Issa P, Hendig D, Scholl HP, Holz FG. Monthly ranibizumab for choroidal neovascularizations secondary to angioid streaks in pseudoxanthoma elasticum: a one-year prospective study. Am J Ophthalmol. 2011 Oct;152(4):695-703. doi: 10.1016/j.ajo.2011.03.022. Epub 2011 Jun 25.
PubMed 21704964
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ranibizumab in Choroidal Neovascularization (CNV) Due to Pseudoxanthoma Elasticum (PXE, Groenblad-Strandberg-Syndrome)
- ClinicalTrials.gov ID
- NCT00510965
- Acronym / sponsor ID
- CRFB002ADE03
- Conditions
- Choroidal Neovascularization
- Keywords
- choroidal neovascularization, angioid streaks, pseudoxanthoma elasticum, Groenblad-Strandberg-Syndrome, therapy, ranibizumab, lucentis, Choroidal neovascularization in patients with PXE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Aug 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 3 Aug 2007 (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 purpose of the study is to investigate the efficacy of a new drug called ranibizumab in the treatment of choroidal neovascularization in underlying angioid streaks due to Pseudoxanthoma elasticum. 10 patients will receive monthly injections of the drug in one eye over a period of one year.
Detailed description
Pseudoxanthoma elasticum (PXE) is a rare hereditary systemic disease affecting mainly the skin, eyes and the cardiovascular system. Commonly, complicating choroidal neovascularization (CNV) of the central retina lead to a severely decreased visual acuity in the course of the disease. Onset of the symptoms varies with the extend of the PXE-associated findings.
In the past there has been no effective treatment for the disease's ocular complications. Recent studies in a limited number of patients with CNV treated with intravitreal injections of bevacizumab, an antagonist targeting vascular endothelial growth factor (VEGF), have shown a preservation of function and regression of CNV. An increase of visual acuity was reported in a subset of patients. Bevacizumab is a humanized antibody of which ranibizumab is a fragment.
This trial is initiated in order to investigate the effect of ranibizumab on functional outcome measures such as preservation of visual acuity as well as morphological outcome measures such as regression of CNV in angiography.
The safety and tolerability of ranibizumab will be investigated as well. As it has been tested on large numbers of patients suffering from age-related macular degeneration with only rare significant side effects or adverse events being reported, a good safety profile is assumed.
The study is conducted in a non-randomized, uncontrolled prospective setting at one center.
Patients will receive monthly injections over a period of one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Intravitreal injection ranibizumab |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of choroidal neovascularization in patients with pseudoxanthoma elasticum
- Age between 18-65 years
- Patient must be able to follow protocol
- Written informed consent
- Genetic diagnosis of pseudoxanthoma elasticum
Key exclusion criteria (18 listed)
- Patients who do not fulfill the inclusion criteria
- Patients with other retinal vascular diseases such as diabetic retinopathy or venous occlusive disease
- Ocular surgery 3 months before study enrollment
- History of uncontrolled glaucoma
- Active intraocular inflammation or inflammation of the ocular adnexa
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 injection ranibizumabAlso: LucentisMonthly intravitreal injection of 0.5mg ranibizumab in one eye over one year | Drug | A |
Primary outcome
Best corrected visual acuity
Time frame: one year
4 secondary outcomes
Reading ability
Time frame: one year
Changes in retinal thickness assessed by optical coherence tomography
Time frame: one year
Changes in parafoveal leakage assessed by fluorescein angiography
Time frame: one year
Quality of life
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2012.
- Derived from this study: PubMed 21704964Finger RP, Charbel Issa P, Hendig D, Scholl HP, Holz FG. Monthly ranibizumab for choroidal neovascularizations secondary to angioid streaks in pseudoxanthoma elasticum: a one-year prospective study. Am J Ophthalmol. 2011 Oct;152(4):695-703. doi: 10.1016/j.ajo.2011.03.022. Epub 2011 Jun 25.
- Related InfoLink provided by the sponsor.
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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.
Frank G. Holz, MD principal investigator
University of Bonn, Department of Ophthalmology
Hendrik PN Scholl, MD, MA principal investigator
University of Bonn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intravitreal injection ranibizumab in people with Choroidal Neovascularization, run by University Hospital, Bonn at 1 site in Germany.
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 6 inclusion and 18 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: finished, as of the sponsor's last update on 15 Jun 2012. 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 Germany. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best corrected visual acuity (time frame: one year). 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 NCT00510965, which also lists 1 linked publication.
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 15 Jun 2012.