Subretinal Macugen for neovascular age-related macular degeneration (SUMANA) - SUMANA

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Subjects meeting all of the following criteria will be considered for admission to the trial:
• adults aged 50 years and older with neovascular AMD proven by fluorescein angiography
• Patients who at baseline
- have a BCVA letter score in the study eye between 20/40 to 20/320 using an ETDRS chart measured at 4 meters or Snellen equivalent
-have a CNV lesion of any type in the study eye with the following characteristics as determined by fluorescein angiography:
- Evidence that CNV extends under the geometric center of the foveal avascular zone.
• Previous state-of-the-art therapy for the disease is deemed ineffective with following characteristics are given:
- Loss of visual acuity (2 or more Snellen lines) in the previous 3 months defined as either
OR
- =10% increase in the lesion diameter as assessed by fluorescein angiography in the
previous 3 months
• Ability of subject to understand character and individual consequences of clinical trial.
• Signed and dated informed consent of the subject must be available before start of any specific trial procedures.
• Women with childbearing potential practicing a medically accepted contraception (negative pregnancy test result, serum or urine at trial entry).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects presenting with any of the following criteria will not be included in the trial:
• have a relevant ocular disease which may be associated with increased intraocular VEGF levels (namely uveitis, neovascular glaucoma, diabetic retinopathy, diabetic maculopathy, ocular ischemic syndrome, retinal vessel occlusion)
• had previous vitrectomy surgery for whatsoever reason
• are not pseudophakic
• have a >50% area of scarring of the whole CNV lesion size as seen in FA
• Arterial hypertension refractory to medical treatment
• Pregnancy and lactation.
• History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
• Participation in other clinical trials during the present clinical trial or within the last 3 months.
• Medical or psychological condition that would not permit completion of the trial or signing of informed consent.
• Suspected or present ocular or periocular infection

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of pegaptanib for neovascular (exudative) age-related macular degeneration (AMD) when the first dose is administered to the subretinal space instead of vitreous body. Following doses will be administered to the vitreous cavity.;Secondary Objective: Safety and tolerability of the new drug administration root (first dose).;Primary end point(s): Proportion of patients who had lost fewer than 15 letters of visual acuity at 54 weeks measured by ETDRS charts

Secondary Outcome Measures

Name	Time	Method

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