- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00211367
Treatment of Radiation Retinopathy With Open-Label Anecortave Acetate Sterile Suspension (15 mg)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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New York
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New York, New York, États-Unis, 10021
- Manhattan Eye, Ear & Throat Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
to investigate the use of anecortave acetate in radiation retinopathy
Délai: 24 months
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24 months
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
mean change of ETDRS VA from baseline to 24 monthe
Délai: 2 years
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2 years
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du système nerveux
- Maladies oculaires
- Blessures et Blessures
- Traumatisme crânio-cérébral
- Traumatisme, système nerveux
- Blessures au visage
- Blessures aux yeux
- Effets physiologiques des médicaments
- Agents antinéoplasiques
- Inhibiteurs de l'angiogenèse
- Agents modulateurs de l'angiogenèse
- Substances de croissance
- Inhibiteurs de croissance
- Anecortave
Autres numéros d'identification d'étude
- AA in Rad.Ret.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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Yu-Hsin HsiehChang Gung University; Jonkoping University; Folke Bernadotte Stiftelsen; Stiftelsen... et autres collaborateursComplétéTroubles de la communication | Appareils d'auto-assistance | Technologie Eye-Gaze | Handicaps physiques gravesSuède