- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01746875
A Study Testing if Medicine Can Make Pigment Epithelium Detachments Regress and Stabilize the Vision in Eyes
September 14, 2015 updated by: Norwegian University of Science and Technology
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Trondheim, Norway, 7489
- Department of neuroscience, NTNU
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Observation
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|
EXPERIMENTAL: Treatment
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.
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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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual acuity from baseline to 6 months
Time Frame: 6 months
|
BCVA on ETDRS will be compared from baseline to 6 months
|
6 months
|
Visual acuity from baseline to 12 months
Time Frame: 12 months
|
BCVA on ETDRS will be compared from baseline to 12 months
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12 months
|
Safety
Time Frame: 24 months
|
Incidence and severity of ocular and non-ocular adverse events will be evaluated through 24 months
|
24 months
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Change in Optical Coherence Tomography (OCT) measurements from baseline through 24 months
Time Frame: 24 months
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Change in OCT Central Retinal Thickness (CRT) and Volume of PED from baseline through 24 months
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24 months
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Development of choroidal neovascularisations (CNV)
Time Frame: 24 months
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Development of CNV seen with OCT, fluorescein and indocyanine green imaging
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24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Tor Elsaas, Prof. MD, Norwegian University of Science and Technology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (ACTUAL)
September 1, 2015
Study Completion (ACTUAL)
September 1, 2015
Study Registration Dates
First Submitted
December 7, 2012
First Submitted That Met QC Criteria
December 10, 2012
First Posted (ESTIMATE)
December 11, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
September 15, 2015
Last Update Submitted That Met QC Criteria
September 14, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Eye Diseases
- Retinal Degeneration
- Retinal Diseases
- Macular Degeneration
- Retinal Detachment
- Dissociative Disorders
- Physiological Effects of Drugs
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Photosensitizing Agents
- Dermatologic Agents
- Verteporfin
- Aflibercept
Other Study ID Numbers
- 2012/1743
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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