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OpenTrials
Completed

NCT Number: NCT00722384

Open Label Study for the Evaluation of Tolerability of Five Dose Levels of Cand5

To establish the tolerability and preliminary efficacy of Cand5 by a single intravitreal injection in patients with wet age-related macular degeneration.

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Key information

Conditions

Macular Degeneration Eye Diseases Retinal Degeneration Retinal Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

OPKO site

Morristown, New Jersey, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with subfoveal predominantly classic, minimally classic and purely occult lesions, secondary to age related macular degeneration, with a total lesion size (including blood, atrophy/scar and neovascularization) of < 12 total disc areas, of which at least 50% are active CNV.
  • Patients must have visual acuity 20/50 to 20/320 in the study eye.
  • Patients must have better visual acuity in the fellow eye than the study eye.
  • Subretinal hemorrhage (if any) must comprise no more than 50% of total lesion size.

Exclusion criteria

  • Patients with concomitant eye disease, including glaucoma, uveitis, diabetic retinopathy, presence of pigment epithelial tears or rips, acute ocular or periocular infection in the study eye.
  • Patients with > 3 prior PDT treatments with Visudyne in the study eye.
  • Patients who received PDT in the study eye within eight weeks prior to the baseline angiography/photography.

Treatment and study plan

Bevasiranib

Drug

Other names: Cand5

Primary outcomes

  1. Complications, including those related to the intravitreal injection, and adverse events, and loss of lines of best-corrected visual acuity, slit lamp findings, lens opacification, intraocular pressure, fundus findings, and laboratory findings.

Secondary outcomes

  1. Stabilization of visual acuity (prevention of loss of three or more lines on the ETDRS chart), stabilization of lesion size, lack of leakage of lesion, or decrease in subretinal fluid

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Sponsors and collaborators

Lead sponsor

OPKO Health, Inc.

Industry

Registry information

Official study title

An Open Label Study for the Evaluation of Tolerability of Five Dose Levels of Cand5 by Single Intravitreal Injection in Patients With Wet Age-Related Macular Degeneration

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Jul 25, 2008
Registry last updated
Jul 25, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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