Informations générales (source: ClinicalTrials.gov)
Long-Term Analysis of DImethyl Fumarate, to Slow the Growth of Areas of Geographic Atrophy (LADIGAGA)
Interventional
Phase 2
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
février 2022
octobre 2027
04 juillet 2024
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).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Lariboisiere-Fernand Widal | SOUIED Eric | 12/04/2024 09:28:53 | Contacter | ||
| CHI DE CRETEIL | Eric SOUIED | 29/03/2024 01:29:29 | Contacter | ||
| HOPITAL FONDATION A. DE ROTHSCHILD | Yannick LE MER | 21/06/2024 13:34:51 | Contacter | ||
Critères
Tous
Inclusion Criteria:
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 defined as one or more
well-defined, usually more or less circular patches of partial or complete
de-pigmentation of the retinal pigment epithelium (RPE), typically with exposure of
underlying choroïdal blood vessels. Even if much of the RPE appears to be preserved
and large choroïdal vessels are not visible, a round patch of RPE partial
de-pigmentation may still be classified as early GA. If a patient has 2 eligible
eyes; one eye will be the "study eye", graded and evaluated during the whole
duration of the study)
- 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 randomized in
the TECFIDERA Group will have to go through the MR Imaging)
- 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
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 defined as one or more
well-defined, usually more or less circular patches of partial or complete
de-pigmentation of the retinal pigment epithelium (RPE), typically with exposure of
underlying choroïdal blood vessels. Even if much of the RPE appears to be preserved
and large choroïdal vessels are not visible, a round patch of RPE partial
de-pigmentation may still be classified as early GA. If a patient has 2 eligible
eyes; one eye will be the "study eye", graded and evaluated during the whole
duration of the study)
- 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 randomized in
the TECFIDERA Group will have to go through the MR Imaging)
- 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
- Participant is in another interventional 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, pseudo-vitelliform macular
degeneration, exudative macular degeneration, moderate/severe myopia)
- 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., triamcinolone) in the
study eye within the last four months prior to study enrollment. Vitamin
supplementation for AMD is not considered an exclusionary criterion
- 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, sirolimus, chronic use of
glucocorticoids) cytotoxic treatments and live attenuated vaccines.(NB: During the
experimental treatment period and 3 months thereafter the concomitant use of
non-authorized treatment cited above is not allowed in patients randomized in the
TEFIDERA group)
- 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: During the experimental
treatment period and 3 months thereafter the concomitant use of non-authorized
nephrotoxic treatment cited above is not allowed in patients randomized in the
TEFIDERA group)
- 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 by a specific oncology consultation
prior to enrollment.)
- 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