An Open Label, Non-Comparative Protocol for Use of Intravitreous Pegaptanib Sodium Injection Every 6 Weeks in Patients With Exudative Age-Related Macular Degeneration (AMD)
Collecte de données
Maladies oculaires+1
+ Dégénérescence Maculaire
+ Maladies de la rétine
Étude thérapeutique
Résumé
Date de début de l'étude : 1 juillet 2004
Date à laquelle le premier participant a commencé l'étude.To provide Pegaptanib sodium injection to patients with subfoveal choroidal neovascularization (CNV) secondary to AMD, who are unable to participate in any of the Sponsor's other clinical studies with this drug for AMD, until such time as the patient's lesion is considered to have resolved or stabilized in the opinion of the treating ophthalmologist, or product becomes commercially available.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 50 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: * Best corrected visual acuity in the study eye between 20/40 and 20/320. * Subfoveal choroidal neovascularization, secondary to age related macular degeneration, with a total lesion size \[including blood, scar/atrophy \& neovascularization\] of \< 12 total disc areas, of which at least 50% must be active CNV. * Any subretinal hemorrhage must comprise no more than 50% of total lesion size. General Criteria: * Patients of either gender, aged greater than 50 years. * Women must be using two forms of effective contraception, or be post-menopausal for at least 12 months prior to study entry, or surgically sterile. If of child-bearing potential, a serum pregnancy test must be performed within 48 hours prior to treatment and the result made available prior to treatment initiation. The two forms of effective contraception must be implemented during the study and for at least 60 days following the last dose of test medication. * Written informed consent. Exclusion Criteria: * Any subfoveal scarring or atrophy and no more than 25% of the total lesion size may be made up of scarring or atrophy. * Patients who are eligible for PDT with Visudyne * Patients who are eligible for any other of the Sponsor's ongoing AMD studies still open to enrollment.
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 20 sites
Connecticut Retina Consultants, L.L.C.
Bridgeport, United StatesNew England Retina Associates
Hamden, United StatesRetina Health Center
Fort Myers, United States