Clinical trial NCT00788177: Subretinal Macugen® for Neovascular Age-Related Macular Degeneration
Official title: Subretinal Macugen® for Neovascular Age-Related Macular Degeneration (SUMANA)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Age-related Macular Degeneration
Keywords: age-related macular degeneration
subretinal injection
Pegaptanib
Macugen
Lead sponsor: Klinikum Ludwigshafen
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2008-11-10
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients who had lost fewer than 15 letters of visual acuity at 54 weeks
timeFrame: 54 weeks
measure: Mean change from baseline in total size of lesion and total size of CNV at 12, 24 and 54 weeks
timeFrame: week 24 and 54
Secondary outcomes:
measure: Changes in best corrected visual acuity (BCVA) from baseline at 54 weeks
timeFrame: 54 weeks
measure: Mean change from baseline in at week 12 and 24
timeFrame: week 12 and 24
measure: Proportion of patients who gain ≥ 5, 10, 15 letters of BCVA from baseline at week 24 and 54
timeFrame: week 24 and 54
measure: Proportion of patients who lose less than 15 letters of BCVA from baseline at week 24 and 54
timeFrame: week 24 and 54
measure: Change in area of leakage at 12, 24 and 54 weeks
timeFrame: weeks 12, 24 and 54
measure: Mean change in retinal thickness by OCT at center of fovea at 12, 24 and 54 weeks
timeFrame: weeks 12, 24 and 54
Other outcomes:
Locations:
city: Ludwigshafen
country: Germany
facility: Department of Ophthalmology, Ludwigshafen hospital
Study officials:
affiliation: Department of ophthalmology, Ludwigshafen hospital
name: Lars-Olof Hattenbach, MD
role: PRINCIPAL_INVESTIGATOR
References: