DDrare: Database of Drug Development for Rare Diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
302	レーベル遺伝性視神経症	1

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT03293524 (ClinicalTrials.gov)	March 12, 2018	19/9/2017	Efficacy & Safety Study of Bilateral IVT Injection of GS010 in LHON Subjects Due to the ND4 Mutation for up to 1 Year	Efficacy and Safety of Bilateral Intravitreal Injection of GS010: A Randomized, Double-Masked, Placebo-Controlled Trial in Subjects Affected With G11778A ND4 Leber Hereditary Optic Neuropathy for Up to One Year	Leber Hereditary Optic Neuropathy	Genetic: GS010;Drug: Placebo	GenSight Biologics	NULL	Active, not recruiting	15 Years	N/A	All	90	Phase 3	United States;Belgium;France;Italy;Spain;Taiwan;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03293524
(ClinicalTrials.gov)

March 12, 2018

19/9/2017

Efficacy & Safety Study of Bilateral IVT Injection of GS010 in LHON Subjects Due to the ND4 Mutation for up to 1 Year

Efficacy and Safety of Bilateral Intravitreal Injection of GS010: A Randomized, Double-Masked, Placebo-Controlled Trial in Subjects Affected With G11778A ND4 Leber Hereditary Optic Neuropathy for Up to One Year

Leber Hereditary Optic Neuropathy

Genetic: GS010;Drug: Placebo

GenSight Biologics

NULL

Active, not recruiting

15 Years

N/A

All

Phase 3

United States;Belgium;France;Italy;Spain;Taiwan;United Kingdom