Pigment Epithelial DetachmentPhase 4NCT00976222
Intravitreal Ranibizumab in Retinal Pigment Epithelial Detachments
A Phase 4 study testing intravitreal injection with ranibizumab in people with Pigment Epithelial Detachment, run by University Hospital Muenster at 2 sites in Germany.
Trial summary
The purpose of this study is to demonstrate the efficacy of ranibizumab in patients with retinal pigment epithelial detachment secondary to age-related macular degeneration (AMD). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Pigment Epithelial Detachment
- What is being tested?
- intravitreal injection with ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesGermany
- Study dates
- Dec 2008to Dec 2015
- Phase
- Phase 4
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with age-related macular degeneration and serous pigment epithelial detachment as determined by fluorescein and indocyanine green angiography and optical coherence tomography (OCT)
- patients who have a best-corrected visual acuity (BCVA) score between 73 and 24 ETDRS letters
- patients with pigment epithelial detachment (PED) ≥ 200 µm as determined by OCT
- male or female patients 50 years of age or greater
- patients willing and able to comply with all study procedures
Who cannot join
- patients with best-corrected visual acuity (BCVA) < 24 or >73 letters in the study eye
- patients previously treated by intravitreal injections of steroids or anti-VEGF agents, or patients previously treated by Verteporfin photodynamic therapy or focal laser photocoagulation
- history of uncontrolled glaucoma in the study eye
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University Hospital Muenchen
München, 80336
University Hospital Muenster
Münster, 48149
About this study
Official title: Intravitreal Ranibizumab in Patients With Retinal Pigment Epithelial Detachments Secondary to Age-related Macular Degeneration
The purpose of this study is to demonstrate the efficacy of ranibizumab in patients with retinal pigment epithelial detachment secondary to age-related macular degeneration (AMD).
Read the detailed description
Pigment epithelial detachments (PED) secondary to age-related macular degeneration (AMD) have been excluded from practically all study populations of ranibizumab studies so far. PED represents a special entity in AMD. As yet, no standard treatment has been established for this disease.The stimuli that induce PED are not very well known, but there is evidence suggesting that angiogenic factors such as vascular endothelial growth factor (VEGF) also play a role in the pathogenesis. Ranibizumab is an anti-VEGF antibody fragment that blocks VEGF activity in patients with neovascular AMD.
- Conditions
- Pigment Epithelial Detachment
- Being tested
- intravitreal injection with ranibizumab
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravitreal injection with ranibizumabDrug
Also called Lucentis
0.5 mg in 0.05 ml, monthly, 12 months
| Study group | Role | What they receive |
|---|---|---|
| 1 Arm Ranibizumab | Other | Not described Receives: Drug: intravitreal injection with ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the efficacy of ranibizumab in patients with retinal pigment epithelial detachment secondary to age-related macular degeneration
Measured: 12 months
Secondary outcomes (5)
Safety
Measured: 12 months
Mean change in best corrected visual acuity
Measured: 12 months
Change in retinal thickness and height of pigment epithelial detachment
Measured: 12 months
Central visual field and stability of fixation
Measured: 12 months
Fluorescein leakage and changes in autofluorescence
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2009 (estimated)
- Study startDec 2008
- Primary completionDec 2014
- Study completionDec 2015
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 Pigment Epithelial DetachmentStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Nicole Eter, University Hospital Muenster
- Investigators
- Nicole Eter, MD, Principal investigator, Dept. of Ophthalmology, University of Muenster Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00976222
- Sponsor's protocol ID
- AMD-PED 08
- Other IDs
- Eudra-CT: 2008-004675-22
- Status last verified
- Sep 2017
- First submitted
- 11 Sep 2009
- Last updated
- 29 Sep 2017
- Results posted
- No
Publications
Clemens CR, Wolf A, Alten F, Milojcic C, Heiduschka P, Eter N. Response of vascular pigment epithelium detachment due to age-related macular degeneration to monthly treatment with ranibizumab: the prospective, multicentre RECOVER study. Acta Ophthalmol. 2017 Nov;95(7):683-689. doi: 10.1111/aos.13359. Epub 2017 Jan 13.
PubMed 28084038
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Ranibizumab in Patients With Retinal Pigment Epithelial Detachments Secondary to Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT00976222
- Acronym / sponsor ID
- AMD-PED 08
- Conditions
- Pigment Epithelial Detachment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Dec 2008
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 14 Sep 2009 (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 this study is to demonstrate the efficacy of ranibizumab in patients with retinal pigment epithelial detachment secondary to age-related macular degeneration (AMD).
Detailed description
Pigment epithelial detachments (PED) secondary to age-related macular degeneration (AMD) have been excluded from practically all study populations of ranibizumab studies so far. PED represents a special entity in AMD. As yet, no standard treatment has been established for this disease.The stimuli that induce PED are not very well known, but there is evidence suggesting that angiogenic factors such as vascular endothelial growth factor (VEGF) also play a role in the pathogenesis. Ranibizumab is an anti-VEGF antibody fragment that blocks VEGF activity in patients with neovascular AMD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 Arm Ranibizumab | Other | Drug: intravitreal injection with ranibizumab |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients with age-related macular degeneration and serous pigment epithelial detachment as determined by fluorescein and indocyanine green angiography and optical coherence tomography (OCT)
- patients who have a best-corrected visual acuity (BCVA) score between 73 and 24 ETDRS letters
- patients with pigment epithelial detachment (PED) ≥ 200 µm as determined by OCT
- male or female patients 50 years of age or greater
- patients willing and able to comply with all study procedures
Key exclusion criteria (3 listed)
- patients with best-corrected visual acuity (BCVA) < 24 or >73 letters in the study eye
- patients previously treated by intravitreal injections of steroids or anti-VEGF agents, or patients previously treated by Verteporfin photodynamic therapy or focal laser photocoagulation
- history of uncontrolled glaucoma in the study eye
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 with ranibizumabAlso: Lucentis0.5 mg in 0.05 ml, monthly, 12 months | Drug | 1 Arm Ranibizumab |
Primary outcome
To investigate the efficacy of ranibizumab in patients with retinal pigment epithelial detachment secondary to age-related macular degeneration
Time frame: 12 months
5 secondary outcomes
Safety
Time frame: 12 months
Mean change in best corrected visual acuity
Time frame: 12 months
Change in retinal thickness and height of pigment epithelial detachment
Time frame: 12 months
Central visual field and stability of fixation
Time frame: 12 months
Fluorescein leakage and changes in autofluorescence
Time frame: 12 months
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 29 Sep 2017.
- Derived from this study: PubMed 28084038Clemens CR, Wolf A, Alten F, Milojcic C, Heiduschka P, Eter N. Response of vascular pigment epithelium detachment due to age-related macular degeneration to monthly treatment with ranibizumab: the prospective, multicentre RECOVER study. Acta Ophthalmol. 2017 Nov;95(7):683-689. doi: 10.1111/aos.13359. Epub 2017 Jan 13.
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.
Nicole Eter, MD principal investigator
Dept. of Ophthalmology, University of Muenster Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing intravitreal injection with ranibizumab in people with Pigment Epithelial Detachment, run by University Hospital Muenster at 2 sites 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 5 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: finished, as of the sponsor's last update on 29 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
To investigate the efficacy of ranibizumab in patients with retinal pigment epithelial detachment secondary to age-related macular degeneration (time frame: 12 months). 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 NCT00976222, 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 29 Sep 2017.