Subretinal Macugen® for Neovascular Age-Related Macular Degeneration

Age-related Macular Degeneration Clinical Trial

Official title:

Subretinal Macugen® for Neovascular Age-Related Macular Degeneration (SUMANA)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00788177
• Other study ID #: AU-06102G
• Status: Recruiting
• Phase: Phase 3
• First received: November 7, 2008
• Last updated: September 26, 2011
• Start date: November 2008
• Est. completion date: December 2012

Study information

• Verified date: July 2009
• Source: Klinikum Ludwigshafen
• Contact: Lars-Olof Hattenbach, MD
• Phone: +49 (621) 503 3051
• Email: hattenbl[@]klilu.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacy of pegaptanib (Macugen®) for neovascular (exudative) age-related macular degeneration (AMD) when the first dose is administered to the submacular space instead of vitreous body in cases when previous state-of-the-art treatment for the AMD was deemed ineffective.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Adults aged 50 years and older with neovascular AMD proven by FA

• 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).

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• Pegaptanib (Macugen®)
Pegaptanib administered to the subretinal space (first dose) and to the vitreous cavity (following doses)

Locations

Country	Name	City	State
Germany	Department of Ophthalmology, Ludwigshafen hospital	Ludwigshafen

Sponsors (2)

Lead Sponsor	Collaborator
Klinikum Ludwigshafen	Pfizer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who had lost fewer than 15 letters of visual acuity at 54 weeks		54 weeks	No
Primary	Mean change from baseline in total size of lesion and total size of CNV at 12, 24 and 54 weeks		week 24 and 54	No
Secondary	Changes in best corrected visual acuity (BCVA) from baseline at 54 weeks		54 weeks	No
Secondary	Mean change from baseline in at week 12 and 24		week 12 and 24	No
Secondary	Proportion of patients who gain = 5, 10, 15 letters of BCVA from baseline at week 24 and 54		week 24 and 54	No
Secondary	Proportion of patients who lose less than 15 letters of BCVA from baseline at week 24 and 54		week 24 and 54	No
Secondary	Change in area of leakage at 12, 24 and 54 weeks		weeks 12, 24 and 54	No
Secondary	Mean change in retinal thickness by OCT at center of fovea at 12, 24 and 54 weeks		weeks 12, 24 and 54	No