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A Safety And Efficacy Study Of ALG-1001 In Human Subjects With Wet Age-Related Macular Degeneration

NCT01749891 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2017-12-15

No results posted yet for this study

Summary

The general objective of this study is to evaluate the safety and efficacy of ophthalmic intravitreal injections of ALG-1001 in human subjects with wet age-related macular degeneration (Wet AMD). This study builds upon the safety and efficacy results of numerous animal studies and an earlier Phase I Human Study in end-stage diabetic macular edema patients.

Conditions

  • Macular Degeneration

Interventions

DRUG

ALG 1001

Patients who will receive three, monthly intravitreal injections of 1.5mg, 2.5mg ,or 4.0 /50μl of ALG-1001 in 0.05cc in isotonic saline solution.

Sponsors & Collaborators

  • Allegro Ophthalmics, LLC

    lead INDUSTRY

Principal Investigators

  • Jose L Guerrero-Narranjo, MD · APEC Hospital Mexico City

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-06-04
Completion
2013-06-07

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01749891 on ClinicalTrials.gov