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NCT01485588 · ClinicalTrials.gov registry record · Phase 1

Safety and Tolerability Study for Age-Related Macular Degeneration

A Phase 1 study of Neovascular Age-related Macular Degeneration, sponsored by Iconic Therapeutics.

Completed
Registry status
Phase 1
Development phase
18
Enrollment target
5
Study locations

NCT01485588: Completed Phase 1 study of Neovascular Age-related Macular Degeneration, sponsored by Iconic Therapeutics.

NCT01485588 is a Phase 1 study of Neovascular Age-related Macular Degeneration that has completed, run by Iconic Therapeutics. The registered enrollment target is 18 participants, below the 408-participant average among 33 other Neovascular Age-related Macular Degeneration trials with a reported enrollment target (96% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01485588, a Phase 1 study of Neovascular Age-related Macular Degeneration, has completed, sponsored by Iconic Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
18 participants
Enrollment target
5
Study locations

Study Summary

Phase 1: The purpose of this study is to evaluate the safety and tolerability of single ascending doses of hI-con1™ for subjects with Age-Related Macular Degeneration. Phase 2: The purpose of this study is to evaluate the safety of 3 injections of hI-con1™ at 2 different dose levels.

Primary Outcome

The Mean Change in Central Retinal Subfield Thickness as Measured by OCT is part of the evaluation on the safety and tolerability of single ascending doses of hI-con1 and to assist in determining the Maximum Tolerated Dose (MTD) that can be administered by intravitreal injection.

Interventions

  • DRUG hI-con1™ 60µl
  • DRUG hI-con1™ 150µl
  • DRUG hI-con1™ 300µl

Study Locations (5)

Texas

  • Retina Research Center - Austin
  • Valley Retina Institute, PA - McAllen

Montana

  • Rocky Mountain Eye Center, P.C. - Missoula

Oregon

  • Retina & Vitreous Center of Southern Oregon, P.C. - Ashland

South Carolina

  • Palmetto Retina Center - West Columbia

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2010-12
Est. Completion 2012-03
Phase Phase 1
Iconic Therapeutics

4 total trials

What the finished NCT01485588 record still lists

NCT01485588 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 408-participant average among 33 other Neovascular Age-related Macular Degeneration trials with a reported enrollment target (96% lower).

The record links to 1 condition, with Neovascular Age-related Macular Degeneration appearing as the primary indexed condition, and to 3 interventions - of which hI-con1™ 60µl is the first listed.

NCT01485588 lists 5 locations in 4 states (Texas, Montana, Oregon).

Frequently Asked Questions

What is clinical trial NCT01485588 about?

NCT01485588 is a clinical study titled "Safety and Tolerability Study for Age-Related Macular Degeneration". Phase 1: The purpose of this study is to evaluate the safety and tolerability of single ascending doses of hI-con1™ for subjects with Age-Related Macular Degeneration. Phase 2: The purpose of this study is to evaluate the safety of 3 injections of hI-con1™ at 2 different dose levels.

What is the current status of trial NCT01485588?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2010-12. Estimated completion is 2012-03.

What conditions does trial NCT01485588 study?

This clinical trial studies the following conditions: Neovascular Age-related Macular Degeneration.

What interventions are being tested in trial NCT01485588?

The interventions under investigation include: hI-con1™ 60µl (DRUG), hI-con1™ 150µl (DRUG), hI-con1™ 300µl (DRUG).

Who is sponsoring clinical trial NCT01485588?

This trial is sponsored by Iconic Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01485588 being conducted?

This trial has 5 study locations across Montana, Oregon, South Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Neovascular Age-related Macular Degeneration

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01485588's enrollment target sits among peer trials

18 32nd of 33 higher than 2 of 33 other Neovascular Age-related Macular Degeneration trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Neovascular Age-related Macular Degeneration trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01485588, the US trial registry maintained by the National Library of Medicine. NCT01485588 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.