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

• Conditions: AGE-RELATED MACULAR DEGENERATIO

• Registration Number: DRKS00000609
• Lead Sponsor: iScience Interventional Corp.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-11
• Study Completion: 2011-10-11
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 21

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

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.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Best-corrected visual acuity <br><br>

Secondary Outcome Measures

Name	Time	Method
Retinal thickness by optical coherence tomography<br><br>