Back to resultsA Study Testing if Medicine Can Make Pigment Epithelium Detachments Regress and Stabilize the Vision in Eyes
Primary Purpose
Macular Degeneration, Retinal Detachment
Status
Terminated
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Aflibercept
Verteporfin
Sponsored by
About this trial
This is an interventional prevention trial for Macular Degeneration focused on measuring Angiogenesis inhibitors, Photochemotherapy, Vascular Endothelium Growth Factors, Aflibercept
Eligibility Criteria
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.
Sites / Locations
- Department of Neuroscience, NTNU
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment
Observation
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Visual acuity from baseline to 6 months
BCVA on ETDRS will be compared from baseline to 6 months
Visual acuity from baseline to 12 months
BCVA on ETDRS will be compared from baseline to 12 months
Safety
Incidence and severity of ocular and non-ocular adverse events will be evaluated through 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
Development of choroidal neovascularisations (CNV)
Development of CNV seen with OCT, fluorescein and indocyanine green imaging
Full Information
NCT ID
NCT01746875
First Posted
December 7, 2012
Last Updated
September 14, 2015
Sponsor
Norwegian University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT01746875
Brief Title
A Study Testing if Medicine Can Make Pigment Epithelium Detachments Regress and Stabilize the Vision in Eyes
Official Title
Pigment Epithelium Detachment - a Prospective Clinical Study. PED-study.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Why Stopped
treatment effects not as desired
Study Start Date
February 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration, Retinal Detachment
Keywords
Angiogenesis inhibitors, Photochemotherapy, Vascular Endothelium Growth Factors, Aflibercept
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Observation
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Aflibercept
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Verteporfin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean change in visual acuity from baseline to 24 months
Description
Best corrected visual acuity (BCVA) on the Early Treatment for Diabetic Retinopathy Study (ETDRS) chart at 4 meters will be compared
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Visual acuity from baseline to 6 months
Description
BCVA on ETDRS will be compared from baseline to 6 months
Time Frame
6 months
Title
Visual acuity from baseline to 12 months
Description
BCVA on ETDRS will be compared from baseline to 12 months
Time Frame
12 months
Title
Safety
Description
Incidence and severity of ocular and non-ocular adverse events will be evaluated through 24 months
Time Frame
24 months
Title
Change in Optical Coherence Tomography (OCT) measurements from baseline through 24 months
Description
Change in OCT Central Retinal Thickness (CRT) and Volume of PED from baseline through 24 months
Time Frame
24 months
Title
Development of choroidal neovascularisations (CNV)
Description
Development of CNV seen with OCT, fluorescein and indocyanine green imaging
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tor Elsaas, Prof. MD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neuroscience, NTNU
City
Trondheim
ZIP/Postal Code
7489
Country
Norway
12. IPD Sharing Statement
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A Study Testing if Medicine Can Make Pigment Epithelium Detachments Regress and Stabilize the Vision in Eyes
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