A Study Testing if Medicine Can Make Pigment Epithelium Detachments Regress and Stabilize the Vision in Eyes

Macular Degeneration Clinical Trial

Official title:

Pigment Epithelium Detachment - a Prospective Clinical Study. PED-study.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01746875
• Other study ID #: 2012/1743
• Status: Terminated
• Phase: N/A
• First received: December 7, 2012
• Last updated: September 14, 2015
• Start date: February 2014
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Macular Degeneration
• Retinal Detachment

Intervention

Drug:
• Aflibercept
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.
• Verteporfin
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.

Locations

Country	Name	City	State
Norway	Department of Neuroscience, NTNU	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 months	No
Secondary	Visual acuity from baseline to 6 months	BCVA on ETDRS will be compared from baseline to 6 months	6 months	No
Secondary	Visual acuity from baseline to 12 months	BCVA on ETDRS will be compared from baseline to 12 months	12 months	No
Secondary	Safety	Incidence and severity of ocular and non-ocular adverse events will be evaluated through 24 months	24 months	Yes
Secondary	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	24 months	No
Secondary	Development of choroidal neovascularisations (CNV)	Development of CNV seen with OCT, fluorescein and indocyanine green imaging	24 months	No