NCT04292080

Brief Summary

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
35mo left

Started Feb 2022

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress59%
Feb 2022Apr 2029

First Submitted

Initial submission to the registry

February 17, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 2, 2020

Completed
1.9 years until next milestone

Study Start

First participant enrolled

February 7, 2022

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2029

Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

5.2 years

First QC Date

February 17, 2020

Last Update Submit

February 2, 2026

Conditions

Age-related Macular Degeneration (AMD)

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline to Month 12 in total area of GA Lesion(s) in the study eye (in mm2) as Measured by Fundus Autofluorescence (FAF)

    12 Months

Secondary Outcomes (1)

  • Incidence and severity of ocular and systemic treatment-related adverse events as assessed by CTCAE v4.0".

    24 months

Study Arms (2)

Group TECFIDERA™

EXPERIMENTAL

Patients will receive oral administration of Dimethyl Fumarate (Tecfidera™) 120 mg twice a day for the first week and then 240 mg of Tecfidera twice a day for 51 weeks following approved standard treatment scheme.

Drug: Dimethyl Fumarate (TECFIDERA™)

No comparator

OTHER

Patients will receive no specific treatment (standard of care) up to 24 months following randomization.

Other: No active : no treatment

Interventions

Dimethyl Fumarate (TECFIDERA™)DRUG

Dimethyl fumarate is a white to off-white powder that is highly soluble in water with a molecular mass of 144.13, containing 120 mg or 240 mg of dimethyl fumarate The starting dose for TECFIDERA is 120 mg twice a day orally. After 7 days, the dose should be increased to the maintenance dose of 240 mg twice a day orally. Body weight, gender, and age do not require dosage adjustment.

Group TECFIDERA™
No active : no treatmentOTHER

Patients will receive no specific treatment (standard of care) up to 24 months following randomization.

No comparator

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 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
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre intercommunal de Créteil

Créteil, Val De Marne, 94000, France

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Interventions

Dimethyl Fumarate

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

FumaratesDicarboxylic AcidsAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Eric SOUIED, PU-PH

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric SOUIED, PU-PH

CONTACT

+33 1 45 17 59 08eric.souied@chicreteil.fr

Serge Camelo, PHD

CONTACT

sergecamelo2@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking is used. All involved know the identity of the intervention assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants receive an intervention throughout the protocol. There are 2 groups : Group 1 : Group TECFIDERA Group 2 : No active (No treatment)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2020

First Posted

March 2, 2020

Study Start

February 7, 2022

Primary Completion (Estimated)

April 7, 2027

Study Completion (Estimated)

April 7, 2029

Last Updated

February 4, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)