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New treatment option for Age-related Macular Degeneration (AMD)
Official title Long-Term Analysis of DImethyl Fumarate, to Slow the Growth of Areas of Geographic Atrophy
ClinicalTrials.gov ID: NCT04292080
What this study is testing
What is Dimethyl Fumarate (TECFIDERA™)?
Dimethyl Fumarate (TECFIDERA™) is an investigational medicine, given as a twice-daily pill taken by mouth, being studied as a potential treatment for age-related macular degeneration (amd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary objectives of the study are to assess the safety, tolerability and evidence of activity of 12 months oral treatment with TEFIDERA® in subjects with Geographic Atrophy associated with Age-Related Macular Degeneration (AMD).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 to 85
You may be able to join if
- Age 55 years of age to 85 years old at the moment of inclusion
- Participant must understand and sign the protocol's informed consent document
- Participant must have central or non-central geographic atrophy (GA) in at least one eye. GA should be at least 0.75 disk areas (DA) in size but no...
- Participant must have a steady fixation in the study eye in the foveal or parafoveal area and media clear enough for good quality photographs
- Participant must have visual acuity between 20/20 and 20/200 in the affected eye
You likely can't join if
- Participant is in another treatment investigational study \< 3 months before inclusion
- Participant is unable to comply with study procedures or follow-up visits
- Participant has evidence of ocular disease other than GA in either eye that may confound the outcome of the study (e.g., glaucoma, diabetic...
- Participant with antecedent of neo-vascular AMD.
- Participant has received treatment for exudative AMD, such as macular laser, photodynamic therapy (PDT) or anti-vascular endothelial growth factor...
- Participant has had a vitrectomy in the study eye
See the full eligibility criteria
Who can join
- Age 55 years of age to 85 years old at the moment of inclusion
- Participant must understand and sign the protocol's informed consent document
- Participant must have central or non-central geographic atrophy (GA) in at least one eye. GA should be at least 0.75 disk areas (DA) in size but no more than 8 disk areas (DA); approximately 2.54 mm2 is 1 DA. (GA is...
- Participant must have a steady fixation in the study eye in the foveal or parafoveal area and media clear enough for good quality photographs
- Participant must have visual acuity between 20/20 and 20/200 in the affected eye
- No suggestive sign of progressive multifocal leukoencephalopathy on brain MR Imaging within 3 months of Tecfidera© treatment Initiation (Only the patients assigned by chance in the TECFIDERA Group will have to go...
- Male participants with female partners capable of conceiving children will be required to use contraception (condom) during the study and for four months after their last experimental treatment caps
- No documented history of heart disease, absence of family history of sudden death, and QTc duration within normal value (\<480ms)
- Participants must be affiliated to a social security scheme
What rules you out
- Participant is in another treatment investigational study \< 3 months before inclusion
- Participant is unable to comply with study procedures or follow-up visits
- Participant has evidence of ocular disease other than GA in either eye that may confound the outcome of the study (e.g., glaucoma, diabetic retinopathy with 10 or more hemorrhages or micro-aneurysms, uveitis...
- Participant with antecedent of neo-vascular AMD.
- Participant has received treatment for exudative AMD, such as macular laser, photodynamic therapy (PDT) or anti-vascular endothelial growth factor (anti-VEGF) therapy intra-vitreal (IVT) injection or of any agent (e.g...
- Participant has had a vitrectomy in the study eye
- Participant is expected to need ocular surgery during the course of the trial
- Participant has undergone lens removal in the last three months or Yttrium Aluminium Garnet (YAG) laser capsulotomy within the last month
- Participant is on chemotherapy
- Participant is on chronic (more than 3 months) immunosuppressive medication administered via ocular or systemic route(s) or is immunosuppressed
- Participant is on ocular or systemic medications known to be toxic to the lens, retina or optic nerve
- Participant with a history of malignancy that would compromise the 2-year study survival
- Participant with a history of ocular herpes simplex virus (HSV)
- Contra-indications or known hyper-sensibility to Dimethyl Fumarate (Tecfidera™) or experimental treatment excipients
- Severe active gastrointestinal disease
- Contra-indications to an MRI using gadolinium such as pace maker, cardiac valve non IRM compatible, cochlear implant or any metallic implant non IRM compatible.
- Any contraindications to gadolinium including pregnancy, previous allergic reaction, severe kidney disease
- Any contraindications to aspirin
- Any screening laboratory value (hematology, serum chemistry or urinalysis) 3 times above normal values or that in the opinion of the Investigator is clinically significant and not suitable for study participation
- Lymphopenia below normal laboratory values at inclusion.
- Severe impairment of a vital organ including severe liver and renal impairment
- Previous organ allograft
- Patients taking the following non-authorized treatment 3 months prior enrolment: other fumaric acid derivatives (topical occular or systemic), immuno-modulators via ocular or systemic routes (including interferons...
- Patients taking the following non-authorized treatment 3 months prior enrolment: nephrotoxic treatment (aminoglycosides, diuretics, nonsteroidal anti-inflammatory drugs (via ocular or systemic routes) or lithium). (NB...
- Any condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control)
- History of cancer (other than a non-melanoma skin cancer) diagnosed within the past five years that could be worsened by immunosuppression (In case of history of cancer the risk of immunosuppression must be determined...
- Ocular or peri-ocular inflammation or infection in either eye
- Presence of active or inactive toxoplasmosis in any or both eye(s)
- Presence of active or latent tuberculosis infection
- Female participants of child bearing potential (those who are not post-menopausal or surgically sterile). Postmenopausal state is 12 months of amenorrhea + high level of FSH if required.
- Persons under curatorship or guardianship
The study team makes the final eligibility decision.
Where it's taking place
- Créteil, Val De Marne, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Créteil, Val De Marne, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.