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The trial is taking place at:
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Strategic Clinical Research Group | Willow Park, TX

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Zimura Compared to Sham in Patients With Autosomal Recessive Stargardt Disease (STGD1)

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Astellas

Status and phase

Active, not recruiting
Phase 2

Conditions

Stargardt's Macular Dystrophy

Treatments

Drug: Sham
Drug: avacincaptad pegol

Study type

Interventional

Funder types

Industry

Identifiers

NCT03364153
OPH2005
2017-004783-35 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of avacincaptad pegol intravitreal injection compared to Sham in participants with autosomal recessive Stargardt disease 1 (STGD1).

Enrollment

121 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • At least two pathogenic mutations of ATP-Binding Cassette (ABC)A4 gene confirmed by a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory
  • Best corrected visual acuity in the study eye between 20/20 - 20/200 Snellen equivalent, inclusive

Exclusion criteria

  • Macular atrophy secondary to any condition other than STGD1 in either eye
  • Any prior treatment for STGD1 including gene therapy, stem cell therapy or any prior intravitreal treatment for any indication in either eye
  • Participation in an interventional study of a vitamin A derivative </= 3 months prior to screening
  • Presence of intraocular inflammation, macular hole, pathologic myopia, epiretinal membrane, evidence of significant vitreo-macular traction, vitreous hemorrhage or aphakia
  • Any intraocular surgery or thermal laser within 3 months of trial entry. Any prior thermal laser in the macular region
  • Diabetes mellitus
  • Hemoglobin A1c (HbA1c) value of >/=6.5%
  • Stroke within 12 months of trial entry
  • Any major surgical procedure within one month of trial entry or anticipated during the trial
  • Any treatment with an investigational agent in the past 60 days for any condition
  • Women who are pregnant or nursing
  • Known serious allergies to the fluorescein dye used in angiography, povidone iodine, or to the components of the avacincaptad pegol formulation

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

121 participants in 2 patient groups

avacincaptad pegol
Experimental group
Description:
Participants will receive avacincaptad pegol monthly for up to 17 Months.
Treatment:
Drug: avacincaptad pegol
Sham
Sham Comparator group
Description:
Participants will receive a matching sham monthly for up to 17 Months.
Treatment:
Drug: Sham

Trial contacts and locations

42

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Central trial contact

Sonia Cruz

Data sourced from clinicaltrials.gov

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