A Study Testing if Medicine Can Make Pigment Epithelium Detachments Regress and Stabilize the Vision in Eyes
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|ClinicalTrials.gov Identifier: NCT01746875|
Recruitment Status : Terminated (treatment effects not as desired)
First Posted : December 11, 2012
Last Update Posted : September 15, 2015
|Condition or disease||Intervention/treatment||Phase|
|Macular Degeneration Retinal Detachment||Drug: Aflibercept Drug: Verteporfin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pigment Epithelium Detachment - a Prospective Clinical Study. PED-study.|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
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.
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.
|No Intervention: Observation|
- 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
- Visual acuity from baseline to 6 months [ Time Frame: 6 months ]BCVA on ETDRS will be compared from baseline to 6 months
- Visual acuity from baseline to 12 months [ Time Frame: 12 months ]BCVA on ETDRS will be compared from baseline to 12 months
- Safety [ Time Frame: 24 months ]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 [ Time Frame: 24 months ]Change in OCT Central Retinal Thickness (CRT) and Volume of PED from baseline through 24 months
- Development of choroidal neovascularisations (CNV) [ Time Frame: 24 months ]Development of CNV seen with OCT, fluorescein and indocyanine green imaging
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01746875
|Department of Neuroscience, NTNU|
|Trondheim, Norway, 7489|
|Principal Investigator:||Tor Elsaas, Prof. MD||Norwegian University of Science and Technology|