Macular DegenerationNCT01746875
A Study Testing if Medicine Can Make Pigment Epithelium Detachments Regress and Stabilize the Vision in Eyes
A study testing Aflibercept and Verteporfin in people with Macular Degeneration and Retinal Detachment, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The purpose of this study is to determine treatment effects in patients with retinal pigment epithelium detachment (PED) in relation to Age Related Maculopathy (AMD). Patients with newly diagnosed PED without choroidal neovascularisations (CNV), will be randomized to either treatment or observation. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration, Retinal Detachment
- What is being tested?
- Aflibercept and Verteporfin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2014to Sep 2015
- Phase
- Interventional
- 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
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age > 50 years
- Pigment epithelium detachment in an eye not earlier treated with anti-VEGF or verteporfin PDT.
- ETDRS Best Corrected Visual acuity 20/32 - 20/400
Who cannot join
- Prior treatment with verteporfin, or external-beam radiation therapy, or transpupillary thermotherapy, Previous subfoveal focal laser photocoagulation involving the foveal center, History of vitrectomy, submacular surgery, or other surgical intervention for AMD.
- CNV, Subfoveal fibrosis or atrophy in study eye.
- Concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy, advanced glaucoma) or require medical or surgical intervention during the study. Active intraocular inflammation in the study eye.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pigment Epithelium Detachment - a Prospective Clinical Study. PED-study.
The purpose of this study is to determine treatment effects in patients with retinal pigment epithelium detachment (PED) in relation to Age Related Maculopathy (AMD). Patients with newly diagnosed PED without choroidal neovascularisations (CNV), will be randomized to either treatment or observation. The treatment group will first be given injections with anti Vascular Endothelium Growth Factor (anti-VEGF). If the injections do not have any effect, Verteporfin Photodynamic Therapy (PDT) will be given. All patients will be followed for a period of 2 years. It is hypothesized that treatment stops the progression of the disease and stabilizes the vision in this subgroup of patients with AMD.
- Conditions
- Macular Degeneration, Retinal Detachment
- Being tested
- Aflibercept, Verteporfin
- Keywords
- Angiogenesis inhibitors, Photochemotherapy, Vascular Endothelium Growth Factors, Aflibercept
- Medical subject headings
- Macular Degeneration, Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfliberceptDrug
2.0 mg monthly x 3 doses, then as needed based on recurrence of activity on OCT. If no effect after the initial 3 doses; 2.0 mg monthly x 3 doses is repeated.
VerteporfinDrug
given if aflibercept does not have any effect. Verteporfin photodynamic therapy is given in combination with aflibercept and triamcinolone. The treatment can be repeated after 3 month.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | aflibercept intravitreal injections, 2.0 mg monthly x 3 doses, then injections as needed based on recurrence of activity on OCT. If no effect of the treatment; aflibercept intravitreal injections, 2.0 mg x 3 doses is repeated, then injections as needed based on recurrence of activity on OCT. If no effect of the treatment; verteporfin photo dynamic therapy. Receives: Drug: Aflibercept; Drug: Verteporfin |
| Observation | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in visual acuity from baseline to 24 months
Best corrected visual acuity (BCVA) on the Early Treatment for Diabetic Retinopathy Study (ETDRS) chart at 4 meters will be compared
Measured: 24 months
Secondary outcomes (5)
Visual acuity from baseline to 6 months
BCVA on ETDRS will be compared from baseline to 6 months
Measured: 6 months
Visual acuity from baseline to 12 months
BCVA on ETDRS will be compared from baseline to 12 months
Measured: 12 months
Safety
Incidence and severity of ocular and non-ocular adverse events will be evaluated through 24 months
Measured: 24 months
Change in Optical Coherence Tomography (OCT) measurements from baseline through 24 months
Change in OCT Central Retinal Thickness (CRT) and Volume of PED from baseline through 24 months
Measured: 24 months
Development of choroidal neovascularisations (CNV)
Development of CNV seen with OCT, fluorescein and indocyanine green imaging
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2012 (estimated)
- Study startFeb 2014
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: treatment effects not as desired
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tor Elsaas, Prof. MD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01746875
- Sponsor's protocol ID
- 2012/1743
- Status last verified
- Sep 2015
- First submitted
- 7 Dec 2012
- Last updated
- 15 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pigment Epithelium Detachment - a Prospective Clinical Study. PED-study.
- ClinicalTrials.gov ID
- NCT01746875
- Acronym / sponsor ID
- 2012/1743
- Conditions
- Macular Degeneration, Retinal Detachment
- Keywords
- Angiogenesis inhibitors, Photochemotherapy, Vascular Endothelium Growth Factors, Aflibercept
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: treatment effects not as desired
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 11 Dec 2012 (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 determine treatment effects in patients with retinal pigment epithelium detachment (PED) in relation to Age Related Maculopathy (AMD). Patients with newly diagnosed PED without choroidal neovascularisations (CNV), will be randomized to either treatment or observation. The treatment group will first be given injections with anti Vascular Endothelium Growth Factor (anti-VEGF). If the injections do not have any effect, Verteporfin Photodynamic Therapy (PDT) will be given. All patients will be followed for a period of 2 years. It is hypothesized that treatment stops the progression of the disease and stabilizes the vision in this subgroup of patients with AMD.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Aflibercept, Drug: Verteporfinaflibercept intravitreal injections, 2.0 mg monthly x 3 doses, then injections as needed based on recurrence of activity on OCT. If no effect of the treatment; aflibercept intravitreal injections, 2.0 mg x 3 doses is repeated, then injections as needed based on recurrence of activity on OCT. If no effect of the treatment; verteporfin photo dynamic therapy. |
| Observation | No intervention | – |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age > 50 years
- Pigment epithelium detachment in an eye not earlier treated with anti-VEGF or verteporfin PDT.
- ETDRS Best Corrected Visual acuity 20/32 - 20/400
Key exclusion criteria (3 listed)
- Prior treatment with verteporfin, or external-beam radiation therapy, or transpupillary thermotherapy, Previous subfoveal focal laser photocoagulation involving the foveal center, History of vitrectomy, submacular surgery, or other surgical intervention for AMD.
- CNV, Subfoveal fibrosis or atrophy in study eye.
- Concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy, advanced glaucoma) or require medical or surgical intervention during the study. Active intraocular inflammation 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 |
|---|---|---|
| Aflibercept2.0 mg monthly x 3 doses, then as needed based on recurrence of activity on OCT. If no effect after the initial 3 doses; 2.0 mg monthly x 3 doses is repeated. | Drug | Treatment |
| Verteporfingiven if aflibercept does not have any effect. Verteporfin photodynamic therapy is given in combination with aflibercept and triamcinolone. The treatment can be repeated after 3 month. | Drug | Treatment |
Primary outcome
Mean change in visual acuity from baseline to 24 months
Time frame: 24 months
Best corrected visual acuity (BCVA) on the Early Treatment for Diabetic Retinopathy Study (ETDRS) chart at 4 meters will be compared
5 secondary outcomes
Visual acuity from baseline to 6 months
Time frame: 6 months
Visual acuity from baseline to 12 months
Time frame: 12 months
Safety
Time frame: 24 months
Change in Optical Coherence Tomography (OCT) measurements from baseline through 24 months
Time frame: 24 months
Development of choroidal neovascularisations (CNV)
Time frame: 24 months
Results and safety
The study was stopped early (reason given: treatment effects not as desired). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2015.
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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.
Tor Elsaas, Prof. MD principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aflibercept and Verteporfin in people with Macular Degeneration and Retinal Detachment, run by Norwegian University of Science and Technology at 1 site in Norway.
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 4 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: stopped early, as of the sponsor's last update on 15 Sep 2015. 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 Norway. 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.
Are results available for this study?
The study was stopped early (reason given: treatment effects not as desired). Results are not available in the source record.
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?
Mean change in visual acuity from baseline to 24 months (time frame: 24 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 Sep 2015.