Subretinal Macugen® for Neovascular Age-Related Macular Degeneration

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

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.

Study Overview

• Status: Unknown
• Conditions: Age-related Macular Degeneration
• Intervention / Treatment: Drug: Pegaptanib (Macugen®)

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Ludwigshafen, Germany, 67063
    • Recruiting
    • Department of Ophthalmology, Ludwigshafen hospital
    • Contact: Lars-Olof Hattenbach, MD; Phone Number: +49 (621) 503 3051; Email: Hattenbl@klilu.de
    • Principal Investigator: Lars-Olof Hattenbach, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients who had lost fewer than 15 letters of visual acuity at 54 weeks	54 weeks
Mean change from baseline in total size of lesion and total size of CNV at 12, 24 and 54 weeks	week 24 and 54

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in best corrected visual acuity (BCVA) from baseline at 54 weeks	54 weeks
Mean change from baseline in at week 12 and 24	week 12 and 24
Proportion of patients who gain ≥ 5, 10, 15 letters of BCVA from baseline at week 24 and 54	week 24 and 54
Proportion of patients who lose less than 15 letters of BCVA from baseline at week 24 and 54	week 24 and 54
Change in area of leakage at 12, 24 and 54 weeks	weeks 12, 24 and 54
Mean change in retinal thickness by OCT at center of fovea at 12, 24 and 54 weeks	weeks 12, 24 and 54

Collaborators and Investigators

• Sponsor: Klinikum Ludwigshafen
• Collaborators: Pfizer
• Investigators: Principal Investigator: Lars-Olof Hattenbach, MD, Department of Ophthalmology, Ludwigshafen hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (ANTICIPATED): March 1, 2012
• Study Completion (ANTICIPATED): December 1, 2012

Study Registration Dates

• First Submitted: November 7, 2008
• First Submitted That Met QC Criteria: November 7, 2008
• First Posted (ESTIMATE): November 10, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): September 27, 2011
• Last Update Submitted That Met QC Criteria: September 26, 2011
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: age-related macular degeneration; Macugen; subretinal injection; Pegaptanib
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: AU-06102G