Age Related Macular DegenerationPhase 2RIPNCT01914159
Ranibizumab In Pigment Epithelium Tears Secondary To Age-Related Macular Degeneration Study
A Phase 2 study testing Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany) in people with Age Related Macular Degeneration, run by University Hospital, Bonn at 3 sites in Germany.
Trial summary
The Ranibizumab in Pigment Epithelium Tears Secondary To Age-Related Macular Degeneration (RIP) Study is a prospective, multicenter, uncontrolled, interventional phase 2 clinical trial that investigates the effect of fixed monthly intravitreal injections of ranibizumab (Lucentis, Novartis Pharma, Germany) on visual… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age Related Macular Degeneration
- What is being tested?
- Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesGermany
- Study dates
- Feb 2013to Mar 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Diagnosis of a pigment epithelial tear secondary to age-related macular degeneration
- Written informed consent
Who cannot join
- Time of diagnosis more than 6 months before study recruitment
- Ocular surgery of the study eye within 1 month before study recruitment
- Extensive subretinal fibrosis or retinal atrophy of the study eye
- Significant opacification of optical media of the study eye
- Uncontrolled glaucoma of the study eye
- Active ocular inflammation of the study eye
- Best-corrected visual acuity of the contralateral eye below 20/200
- Concurrent ocular or systemic therapy with other vascular endothelial growth factor (VEGF)-inhibitory drugs
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
University of Bonn, Department of Ophthalmology
Bonn, 53127
University of München (LMU), Department of Ophthalmology
München, 80336
Universityof Münster, Department of Ophthalmology
Münster, 48149
About this study
The Ranibizumab in Pigment Epithelium Tears Secondary To Age-Related Macular Degeneration (RIP) Study is a prospective, multicenter, uncontrolled, interventional phase 2 clinical trial that investigates the effect of fixed monthly intravitreal injections of ranibizumab (Lucentis, Novartis Pharma, Germany) on visual acuity and retinal morphology over a study period of 12 months in 30 patients.
- Conditions
- Age Related Macular Degeneration
- Being tested
- Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany)
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany)Drug
Monthly intravitreal injections
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab | Experimental | Not described Receives: Drug: Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best-corrected Visual Acuity
Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol
Measured: 12 months
Secondary outcomes (2)
Retinal Morphology
Spectral-domain optical coherence tomography (SD-OCT) central retinal thickness
Measured: 12 months
Vision-related Quality of Life
National Eye Institute Visual Function Questionaire 25-item version (NEI VFQ-25)
0 to 100 scale, where 100 represents the best possible score and 0 represents the worst
Reference: Mangione CM et al. Arch Ophthalmol 2001 Jul;119(7):1050-8.
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 posted1 Aug 2013 (estimated)
- Study startFeb 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Age Related Macular DegenerationStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frank G. Holz, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914159
- Sponsor's protocol ID
- N-037.0156
- Acronym
- RIP
- Status last verified
- Jul 2019
- First submitted
- 28 Jul 2013
- Last updated
- 15 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ranibizumab In Pigment Epithelium Tears Secondary To Age-Related Macular Degeneration Study
- ClinicalTrials.gov ID
- NCT01914159
- Acronym / sponsor ID
- RIP / N-037.0156
- Conditions
- Age Related Macular Degeneration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 1 Aug 2013 (estimated)
- Results
- Posted 15 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Ranibizumab in Pigment Epithelium Tears Secondary To Age-Related Macular Degeneration (RIP) Study is a prospective, multicenter, uncontrolled, interventional phase 2 clinical trial that investigates the effect of fixed monthly intravitreal injections of ranibizumab (Lucentis, Novartis Pharma, Germany) on visual acuity and retinal morphology over a study period of 12 months in 30 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab | Experimental | Drug: Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of a pigment epithelial tear secondary to age-related macular degeneration
- Written informed consent
Key exclusion criteria (8 listed)
- Time of diagnosis more than 6 months before study recruitment
- Ocular surgery of the study eye within 1 month before study recruitment
- Extensive subretinal fibrosis or retinal atrophy of the study eye
- Significant opacification of optical media of the study eye
- Uncontrolled glaucoma of 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 |
|---|---|---|
| Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany)Monthly intravitreal injections | Drug | Ranibizumab |
Primary outcome
Best-corrected Visual Acuity
Time frame: 12 months
Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol
2 secondary outcomes
Retinal Morphology
Time frame: 12 months
Vision-related Quality of Life
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany) in people with Age Related Macular Degeneration, run by University Hospital, Bonn at 3 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 2 inclusion and 8 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 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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?
Yes. Results are posted in the registry (first posted 15 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2019.