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A Retrospective Trial of Suprachoroidal Drug Therapy for Advanced Exudative Age-Related Macular Degeneration

A Retrospective Trial of Suprachoroidal Drug Therapy for Advanced Exudative Age-Related Macular Degeneration - Retrospective HAS-EU-2010 Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00000609
Enrollment
25
Registered
2011-04-11
Start date
2011-04-12
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AGE-RELATED MACULAR DEGENERATION

Interventions

Group 1: Retrospective chart review of patients with advanced, exudative age-related macular degeneration who have undergone submacular suprachoroidal drug administration.

Sponsors

iScience Interventional Corp.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
55 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1. Patients must have been 55 years of age or older at the time of surgery. 2. Patients must have CNV extending beneath the geometric center of the foveal avascular zone secondary to advanced, exudative age-related macular degeneration. 3. The study eye was not a candidate for conventional commercially available approved treatments such as laser, photodynamic therapy, or intravitreal injections of Macugen™, Lucentis™, or Avastin™ or failed initial therapies with documentation of results from the three most recent treatments. 4. The eye was treated with submacular suprachoroidal drug administration of a combination of bevacizumab and triamcinolone acetonide. 5. Patient’s best corrected visual acuity (BCVA) was 20/40 or worse Snellen equivalent using ETDRS. 6. The eye has follow-up data to 12 months.

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1. Features of any condition other than age-related macular degeneration (such as myopic degeneration or ocular histoplasmosis) associated with the CNV in the study eye, or any ocular disease other than AMD with CNV that could adversely affect assessments of vision in that eye. 2. Cataract surgery or refractive surgery after baseline examination and prior to completion of the 12 month follow-up period that would affect assessment of vision. 3. Difficulty in obtaining photographic or angiographic documentation of the CNV. 4. Subjects must not have had prior intraocular surgery or have received PDT, conventional laser therapy, or any other treatment for exudative AMD within 1 month of suprachoroidal drug administration. 5. Subjects must not have a history of an abnormal elevation of intraocular pressure in response to systemic, intraocular, topical or periocular steroids. 6. Subject was enrolled in another ophthalmic clinical trial.

Design outcomes

Primary

MeasureTime frame
Best-corrected visual acuity

Secondary

MeasureTime frame
Retinal thickness by optical coherence tomography

Countries

Germany

Contacts

Public ContactStephanie Baba

iScience Interventional Corp.

clinical@iscienceinterventional.com650-421-2700

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026