Age Related Macular DegenerationPhase 2MONETNCT00713518
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).
A Phase 2 study testing 0.5 mg ranibizumab, 3 mg PF-04523655 and 1 mg PF-04523655 in people with Age Related Macular Degeneration, run by Quark Pharmaceuticals at 31 sites in 11 countries.
Trial summary
The aim of the study is to evaluate whether PF-04523655 is effective in the treatment of neovascular/wet AMD and at which dose. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age Related Macular Degeneration
- What is being tested?
- 0.5 mg ranibizumab, 3 mg PF-04523655 and 1 mg PF-04523655
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 31 sitesin 11 countries
- Study dates
- Nov 2009to Jul 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
31 sites in 11 countries.
31 sites in 11 countries
United States7 sites
Pfizer Investigational Site
Augusta, Georgia, 30909
Pfizer Investigational Site
Austin, Texas, 78705
Pfizer Investigational Site
Cleveland, Ohio, 44195
Pfizer Investigational Site
Fort Myers, Florida, 33912
Pfizer Investigational Site
Indianapolis, Indiana, 46290
Pfizer Investigational Site
San Francisco, California, 94143
Pfizer Investigational Site
Winter Haven, Florida, 33880
Israel5 sites
Pfizer Investigational Site
Kfar Saba, 44281
Pfizer Investigational Site
Petah Tikva, 49100
Pfizer Investigational Site
Tel Aviv, 64239
Pfizer Investigational Site
Tel Litwinsky, 52621
Pfizer Investigational Site
Ẕerifin, 70300
India4 sites
Pfizer Investigational Site
Ahmedabad, Gujarat, 380 004
Pfizer Investigational Site
Coimbatore, Tamil Nadu, 641014
Pfizer Investigational Site
Navrangpura, Ahmedabad, Gujarat, 380009
Pfizer Investigational Site
New Delhi, 110029
Philippines3 sites
Pfizer Investigational Site
Makati City, 1200
Pfizer Investigational Site
Manila, 1008
Pfizer Investigational Site
Quezon City, 1113
South Korea3 sites
Pfizer Investigational Site
Seoul, 110-744
Pfizer Investigational Site
Seoul, 135-710
Pfizer Investigational Site
Seoul, 138-736
Spain3 sites
Pfizer Investigational Site
Alicante, Alicante, 03016
Pfizer Investigational Site
Barcelona, Barcelona, 08035
Pfizer Investigational Site
Valencia, Valencia, 46014
Austria2 sites
Pfizer Investigational Site
Linz, A-4021
Pfizer Investigational Site
Vienna, A-1030
About this study
Official 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).
The aim of the study is to evaluate whether PF-04523655 is effective in the treatment of neovascular/wet AMD and at which dose.
- Conditions
- Age Related Macular Degeneration
- Being tested
- 0.5 mg ranibizumab, 3 mg PF-04523655, 1 mg PF-04523655
- Keywords
- AMD Age Related Macular Degeneration Choroidal Neovascularization Monet
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5 mg ranibizumabDrug
Also called Lucentis
3 mg PF-04523655Drug
1 mg PF-04523655Drug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 ranibizumab | Active comparator | 0.5 mg ranibizumab intravitreal injection given every 4 weeks from baseline to Week 12 Receives: Drug: 0.5 mg ranibizumab |
| Arm 2 ranibizumab and PF-04523655 | Experimental | 0.5 mg ranibizumab given by intravitreal injection at baseline followed by 3 mg PF-04523655 given by intravitreal injection every 2 weeks from Week 4 to Week 12 Receives: Drug: 0.5 mg ranibizumab; Drug: 3 mg PF-04523655 |
| Arm 3 ranibizumab and PF-04523655 | Experimental | 0.5 mg ranibizumab given by intravitreal injection at baseline followed by 1 mg PF-04523655 given by intravitreal injection evey 4 weeks to Week 12 Receives: Drug: 0.5 mg ranibizumab; Drug: 1 mg PF-04523655 |
| Arm 4 ranibizumab and PF-04523655 | Experimental | 0.5 mg ranibizumab given by intravitreal injection at baseline followed by 3 mg of PF-04523655 given by intravitreal injection every 4 weeks from Week 4 to Week 12 Receives: Drug: 0.5 mg ranibizumab; Drug: 3 mg PF-04523655 |
| Arm 5 ranibizumab and PF-04523655 | Experimental | 0.5 mg ranibizumab given by intravitreal injection at baseline followed by 1 mg of PF-04523655 (30 minutes later) given in combination every 4 weeks from baseline to Week 12 Receives: Drug: 0.5 mg ranibizumab; Drug: 1 mg PF-04523655 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in the best corrected visual acuity score measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol by Week 16
Measured: Week 16
Secondary outcomes (6)
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
Measured: Week 16
Mean change from Baseline over time (16 weeks) in the best corrected visual acuity score, as measured using the ETDRS protocol
Measured: Week 16
Incidence and severity of ocular adverse events identified by ophthalmic examination and or spontaneously reported
Measured: Week 48
Change from Baseline to Weeks 4,8, 12, and 16 in retinal central subfield thickness and retinal lesion thickness assessed by OCT
Measured: Week 16
Incidence and severity of systemic adverse events identified by physical examination, changes in vital signs, clinical laboratory abnormalities and or spontaneously reported
Measured: Week 48
Change from Baseline in lesion size on FFA at Week 16
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2008 (estimated)
- Study startNov 2009
- Primary completionNov 2010
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quark Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00713518
- Sponsor's protocol ID
- B0451001
- Acronym
- MONET
- Status last verified
- Oct 2012
- First submitted
- 7 Jul 2008
- Last updated
- 12 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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).
- ClinicalTrials.gov ID
- NCT00713518
- Acronym / sponsor ID
- MONET / B0451001
- Conditions
- Age Related Macular Degeneration
- Keywords
- AMD Age Related Macular Degeneration Choroidal Neovascularization Monet
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Quark PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- Nov 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 11 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to evaluate whether PF-04523655 is effective in the treatment of neovascular/wet AMD and at which dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 1 ranibizumab | Active comparator | Drug: 0.5 mg ranibizumab0.5 mg ranibizumab intravitreal injection given every 4 weeks from baseline to Week 12 |
| Arm 2 ranibizumab and PF-04523655 | Experimental | Drug: 0.5 mg ranibizumab, Drug: 3 mg PF-045236550.5 mg ranibizumab given by intravitreal injection at baseline followed by 3 mg PF-04523655 given by intravitreal injection every 2 weeks from Week 4 to Week 12 |
| Arm 3 ranibizumab and PF-04523655 | Experimental | Drug: 0.5 mg ranibizumab, Drug: 1 mg PF-045236550.5 mg ranibizumab given by intravitreal injection at baseline followed by 1 mg PF-04523655 given by intravitreal injection evey 4 weeks to Week 12 |
| Arm 4 ranibizumab and PF-04523655 | Experimental | Drug: 0.5 mg ranibizumab, Drug: 3 mg PF-045236550.5 mg ranibizumab given by intravitreal injection at baseline followed by 3 mg of PF-04523655 given by intravitreal injection every 4 weeks from Week 4 to Week 12 |
| Arm 5 ranibizumab and PF-04523655 | Experimental | Drug: 0.5 mg ranibizumab, Drug: 1 mg PF-045236550.5 mg ranibizumab given by intravitreal injection at baseline followed by 1 mg of PF-04523655 (30 minutes later) given in combination every 4 weeks from baseline to Week 12 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.5 mg ranibizumabAlso: Lucentis | Drug | Arm 1 ranibizumab, Arm 2 ranibizumab and PF-04523655, Arm 3 ranibizumab and PF-04523655, Arm 4 ranibizumab and PF-04523655, Arm 5 ranibizumab and PF-04523655 |
| 3 mg PF-04523655 | Drug | Arm 2 ranibizumab and PF-04523655, Arm 4 ranibizumab and PF-04523655 |
| 1 mg PF-04523655 | Drug | Arm 3 ranibizumab and PF-04523655, Arm 5 ranibizumab and PF-04523655 |
Primary outcome
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
6 secondary outcomes
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
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
Incidence and severity of ocular adverse events identified by ophthalmic examination and or spontaneously reported
Time frame: Week 48
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
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
Change from Baseline in lesion size on FFA at Week 16
Time frame: Week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2012.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
31 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 0.5 mg ranibizumab, 3 mg PF-04523655 and 1 mg PF-04523655 in people with Age Related Macular Degeneration, run by Quark Pharmaceuticals at 31 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Israel, India, Philippines, South Korea and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2012; AzTrials last refreshed its copy on 31 Oct 2026.