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Treatment of Radiation Retinopathy With Open-Label Anecortave Acetate Sterile Suspension (15 mg)

20. juni 2007 oppdatert av: Manhattan Eye, Ear & Throat Hospital

Radiation retinopathy is a disease of the retina. It occurs in people who have received or been exposed to radiation near the eyes. The blood vessels are abnormal and may grow which lead to scarring and a loss of central vision. Currently, the treatment for radiation retinopathy is laser photocoagulation. This treatment has been found to have limited use in this type of condition. Compassionate use of anecortave acetate injection is being considered to prevent the growth of the blood vessels under the retina.

Studieoversikt

Status

Avsluttet

Forhold

Øyeskader

Intervensjon / Behandling

Legemiddel: Anecortave Acetate

Detaljert beskrivelse

Patients will receive an injection of 15 mg of Anecortave acetate behind the eye to be treated ("study eye"). They will be evaluated every six months to determine if their condition is stable or worse. Following the injection of study medication, patients will not be required to come in to see the study physician. The investigator or study staff will call the patients on the day following injection to make sure there were no adverse effects to the injection. Patients will then come in for a Month 1 and a Month 3 follow-up visit. At the Month 3 follow-up visit, if patients are not showing stability or improvement, they may be offered either thermal laser or Photodynamic Therapy. They will remain in the study and remain eligible for a repeat injection of Anecortave Acetate at the Month 6 visit.

Patients will then been seen at Month 6 for a Re-treatment Evaluation Visit. If their condition is stable, they will be offered re-injection with the same study medication they received earlier. If Patients are not showing stability or improvement at the Month 6 visit, they may be offered thermal laser or Photodynamic Therapy in conjunction with the Anecortave Acetate injection.

Patients will then come back again for a Month 1 and a Month 3 visit and an Exit Visit, if necessary. If the patient's condition is worse, patients will be exited from this study and offered standard treatment.

Studietype

Intervensjonell

Registrering (Faktiske)

Fase

Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Forente stater
- New York
  - New York, New York, Forente stater, 10021
    - Manhattan Eye, Ear & Throat Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

N/A

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

Clinical diagnosis of radiation retinopathy.
Patients must be 18 years of age or older to receive treatment.
Visual acuity of 20/30 to 20/320 in study eye on the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity chart
Visual acuity of 20/800 or better in fellow eye on the ETDRS visual acuity chart.

Exclusion Criteria:

Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.
Patients who have undergone intraocular surgery within the last 2 months
Patient participating in any other investigational drug study.
Use of an investigational drug or treatment related or unrelated to their condition within 30 days prior to receipt of study medication.
Inability to obtain photographs to document choroidal neovascularization (CNV) (including difficulty with venous access)
Patient with significant liver disease or uremia.
Patient with known adverse reaction to fluorescein and indocyanine green or iodine.
Patient has a history of any medical condition which would preclude scheduled visits or completion of study
Patient has had insertion of scleral buckle in the study eye
Patient has received radiation treatment
Patient is on anticoagulant therapy with the exception of aspirin
Patient is pregnant or nursing.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Behandling
Tildeling: Ikke-randomisert
Intervensjonsmodell: Enkeltgruppeoppdrag
Masking: Ingen (Open Label)

Hva måler studien?

Primære resultatmål

Resultatmål	Tidsramme
to investigate the use of anecortave acetate in radiation retinopathy Tidsramme: 24 months	24 months

Sekundære resultatmål

Resultatmål	Tidsramme
mean change of ETDRS VA from baseline to 24 monthe Tidsramme: 2 years	2 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Manhattan Eye, Ear & Throat Hospital

Samarbeidspartnere

Alcon Research

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2004

Studiet fullført (Faktiske)

1. mars 2007

Datoer for studieregistrering

Først innsendt

13. september 2005

Først innsendt som oppfylte QC-kriteriene