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Clinical Trials/NCT03452527
NCT03452527
Terminated
Phase 2

A Phase 2 Randomized, Open-Label, Multicenter Study Evaluating Administration of Repeated Intravitreal Doses of ICON-1 in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration

Iconic Therapeutics, Inc.8 sites in 1 country15 target enrollmentMarch 26, 2018

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Choroidal Neovascularization
Sponsor
Iconic Therapeutics, Inc.
Enrollment
15
Locations
8
Primary Endpoint
Change in Choroidal Neovascularization (CNV) Over Time
Status
Terminated
Last Updated
5 years ago

Overview

Brief Summary

The purpose of this study is to evaluate the safety and effects of repeated intravitreal injections of ICON-1 0.6 mg administered as maintenance therapy or in combination with aflibercept in patients with wet macular degeneration.

Registry
clinicaltrials.gov
Start Date
March 26, 2018
End Date
April 25, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Males or females of any race, ≥50 years of age
  • Active primary CNV secondary to AMD in the study eye

Exclusion Criteria

  • Any prior treatment of CNV or advanced AMD in the study eye, except for dietary supplements or vitamins
  • Any intraocular or ocular surface surgery (including cataract surgery and laser procedures) in the study eye within 3 months
  • Vitrectomy in the study eye

Outcomes

Primary Outcomes

Change in Choroidal Neovascularization (CNV) Over Time

Time Frame: Month 9

Mean change from baseline in CNV area in the study eye

Secondary Outcomes

  • Change in Best Corrected Visual Acuity (BCVA) Over Time(Month 9)

Study Sites (8)

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