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

NCT01746875 | Terminated DMC

• 1 other identifier: 2012/1743
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Macular Degeneration; Retinal Detachment

Keywords

Angiogenesis inhibitors; Photochemotherapy; Vascular Endothelium Growth Factors; Aflibercept

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Visual acuity from baseline to 6 months

  6 months

• Visual acuity from baseline to 12 months

  12 months

• Safety

  24 months

• Change in Optical Coherence Tomography (OCT) measurements from baseline through 24 months

  24 months

• Development of choroidal neovascularisations (CNV)

  24 months

Study Arms (2)

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.

Drug: Aflibercept; Drug: Verteporfin

Observation

NO INTERVENTION

Interventions

Aflibercept DRUG

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.

Treatment

Verteporfin DRUG

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.

Treatment

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead

Study Sites (1)

Department of Neuroscience, NTNU

Trondheim, 7489, Norway

Location

MeSH Terms

Conditions

Macular Degeneration; Retinal Detachment

Interventions

aflibercept; Verteporfin

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Tor Elsaas, Prof. MD

  Norwegian University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2012
• First Posted: December 11, 2012
• Study Start: February 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 15, 2015

Record last verified: 2015-09

Locations

NO (1)