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Completed

NCT Number: NCT00713518

Phase II Open Label Multicenter Study For Age Related Macular Degeneration Comparing PF-04523655 Versus Lucentis In The Treatment Of Subjects With CNV (MONET Study).

The aim of the study is to evaluate whether PF-04523655 is effective in the treatment of neovascular/wet AMD and at which dose.

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Key information

Conditions

Age Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Linz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females age 50 years or older with active primary or recurrent subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). Active CNV is defined as any leakage detected on FFA or OCT. Note: Female subjects 50- 60 years of age must be amenorrheic for at least 2 years and have a serum FSH level within the laboratory reference range for postmenopausal women
  • The total area of CNV (including both classic and occult components) encompassed within the lesion must be 50% or more of the total lesion area.
  • The total lesion size ≤12 disc areas.
  • Best corrected visual acuity using ETDRS protocol of 20/40 to 20/320 (letter score ≤73) in the study eye at the screening visit.
  • Best corrected visual acuity score in the fellow eye of 20/400 or better (letter score of ≥19) at the Screening Visit. Note: Only one eye will be treated (study eye) through the duration of the study. In the event both eyes are eligible for study entry the study eye should be selected by the investigator and subject. The non-study eye may be treated with an approved AMD therapy
  • Subject has retinal central subfield thickness ≥250µm measured using Stratus OCT.

Exclusion criteria

  • Prior treatment with verteporfin photodynamic therapy, external-beam radiation therapy, or transpupillary thermotherapy in the study eye
  • Previous subfoveal focal laser photocoagulation in the study eye
  • Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Baseline
  • History of vitrectomy, submacular surgery or other surgical intervention for AMD in the study eye
  • Previous participation in any studies with investigational drugs or treatments administered 1 month preceding Baseline visit such as systemic glucocorticoids, ocular or periocular steroids (eg, triamcinolone, anecortave acetate), anti-angiogenic drugs such as pegaptanib (Macugen), ranibizumab (Lucentis), bevacizumab (Avastin) in the study eye
  • Subretinal hemorrhage in the study eye that involves the fovea, if the size of the hemorrhage is either 50% or more of the total lesion area or 1 or more disc areas in size
  • CNV in either eye of other etiology, eg, ocular histoplasmosis, trauma, or pathologic myopia
  • Presence of subfoveal scarring
  • Retinal pigment epithelial tear involving the macula in the study eye

Treatment and study plan

0.5 mg ranibizumab

Drug

Other names: Lucentis

3 mg PF-04523655

Drug

1 mg PF-04523655

Drug

Primary outcomes

  1. Mean change in the best corrected visual acuity score measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol by Week 16

    Time frame: Week 16

Secondary outcomes

  1. Percent of subjects gaining >/=15 letters in the best corrected visual acuity score at 16 weeks compared to Baseline, as measured using the ETDRS protocol

    Time frame: Week 16

  2. Mean change from Baseline over time (16 weeks) in the best corrected visual acuity score, as measured using the ETDRS protocol

    Time frame: Week 16

  3. Incidence and severity of ocular adverse events identified by ophthalmic examination and or spontaneously reported

    Time frame: Week 48

  4. Change from Baseline to Weeks 4,8, 12, and 16 in retinal central subfield thickness and retinal lesion thickness assessed by OCT

    Time frame: Week 16

  5. Incidence and severity of systemic adverse events identified by physical examination, changes in vital signs, clinical laboratory abnormalities and or spontaneously reported

    Time frame: Week 48

  6. Change from Baseline in lesion size on FFA at Week 16

    Time frame: Week 16

Sponsors and collaborators

Lead sponsor

Quark Pharmaceuticals

Industry

Collaborators

  • Pfizer

Registry information

Official study title

Phase II Open Label Multicenter, Prospective, Randomized, Age Related Macular Degeneration, Comparator Controlled Study Evaluating PF-04523655 Versus Ranibizumab In The Treatment Of Subjects With Choroidal Neovascularization (MONET Study).

Acronym: MONET

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Jul 11, 2008
Registry last updated
Oct 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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