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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01319487




Registration number
NCT01319487
Ethics application status
Date submitted
18/03/2011
Date registered
21/03/2011
Date last updated
23/08/2012

Titles & IDs
Public title
Safety and Efficacy Study of Topical Administration of FOV2304 (High Dose or Low Dose) for the Treatment of Center-involving Clinically Significant Macular Edema Associated With Diabetic Retinopathy
Scientific title
A 6-month, Phase II, Double-masked, Multicenter, Randomized, Placebo Controlled, Parallel Group Study to Assess the Safety and Efficacy of Topical Administration of Two Concentrations of FOV2304 (High Dose or Low Dose) for the Treatment of Center-involving Clinically Significant Macular Edema Associated With Diabetic Retinopathy
Secondary ID [1] 0 0
FOV2304/CLIN/201/P
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Macular Edema 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Metabolic and Endocrine 0 0 0 0
Diabetes
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 2304 Eye Drops High Dose
Treatment: Drugs - 2304 Eye Drops Low Dose
Treatment: Drugs - Placebo Eye Drops

Experimental: 2304 Eye Drops High Dose - 2304 Eye Drops High Dose self-administered in the study eye during the treatment period

Experimental: 2304 Eye Drops Low Dose - 2304 Eye Drops Low Dose self-administered in the study eye during the treatment period

Placebo comparator: Placebo Eye Drops - Placebo Eye Drops self-administered in the study eye during the treatment period


Treatment: Drugs: 2304 Eye Drops High Dose
2304 Eye Drops High Dose self-administered in the study eye during the treatment period

Treatment: Drugs: 2304 Eye Drops Low Dose
2304 Eye Drops Low Dose self-administered in the study eye during the treatment period

Treatment: Drugs: Placebo Eye Drops
Placebo Eye Drops self-administered in the study eye during the treatment period
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
change from baseline of central retinal thickness as determined by logOCT
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Proportion of patients with an improvement in best corrected visual acuity (BCVA)
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Change in macular volume and retinal thickness from baseline to Week 12 and Week 24
Timepoint [2] 0 0
Baseline, Week 12, Week 24

Eligibility
Key inclusion criteria
Main inclusion/exclusion criteria are listed below. Others may apply.



1. Male or female, at least 18 years of age.
2. Diagnosis of diabetes mellitus
3. Patient must be able to self administer study drug.
4. Clinically significant diabetic macular edema in at least one eye ("study eye") involving the center of the macula:
5. Mild to severe non proliferative diabetic retinopathy (Early Treatment Diabetic Retinopathy Study [ETDRS] grade between 20 and 53).
6. BCVA score = 34 letters and < 80 letters in the study eye.
7. Women of childbearing potential must have a negative urine pregnancy test at Screening and be using two highly effective methods of contraception throughout the study.
8. Male patients with partners of childbearing potential must agree to use at least one highly effective method of contraception throughout the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Ocular conditions:

1. Any ocular condition in the study eye that in the opinion of the investigator would prevent improvement in visual acuity.
2. Proliferative diabetic retinopathy in the study eye.
3. History of panretinal scatter photocoagulation(PRP)in the study eye within 4 months prior to screening, and/or anticipated need for PRP in the 3 months following randomization.
4. Active optic disc or retinal neovascularization, rubeosis iridis, active or history of choroidal neovascularization in the study eye.
5. History of pars plana vitrectomy at any time, intraocular surgery in the study eye within 90 days prior to screening.
6. History of use of intravitreal injectable or periocular depots corticosteroids (other than triamcinolone acetonide)within 3 months prior to the screening visit in the study eye.
7. Patients who have previously received triamcinolone acetonide in the study eye:

* The intended dose for each triamcinolone acetonide injection was more than 4 mg.
* The most recent dose was less than 3 months prior to the screening visit.
* Any treatment-related adverse event that was seen, and in the opinion of the investigator, has the potential to worsen or reoccur with study treatment.
8. Patients who have previously received anti-VEGF therapy within 3 months prior to the screening visit in the study eye.
9. Uncontrolled glaucoma or glaucoma treated by 2 or more medications.
10. Aphakia or intraocular lens placement in the anterior chamber of the study eye.
11. Any active ocular infection; any history of recurrent or chronic infection or inflammation in the study eye.
12. History of herpetic infection in either eye.
13. History of corneal pathology/surgery
14. Contact lens use at any time during the study.

Systemic conditions:
15. Uncontrolled systemic disease.
16. Poorly controlled diabetes mellitus.
17. Impaired renal function
18. Poorly controlled arterial hypertension

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2012
Sample size
Target
Accrual to date
Final
267
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Center 2003 - Chatswood
Recruitment hospital [2] 0 0
Center 2002 - Melbourne
Recruitment hospital [3] 0 0
Center 2004 - Murdoch
Recruitment hospital [4] 0 0
Center 2001 - Sydney
Recruitment postcode(s) [1] 0 0
- Chatswood
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment postcode(s) [3] 0 0
- Murdoch
Recruitment postcode(s) [4] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
Florida
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United States of America
State/province [3] 0 0
Illinois
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United States of America
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Indiana
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United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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Pennsylvania
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United States of America
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Tennessee
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United States of America
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Texas
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Belgium
State/province [12] 0 0
Antwerpen
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Belgium
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Brussels
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Belgium
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Wilrijk
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Czech Republic
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Brno
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Czech Republic
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Hradec Kralove
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Czech Republic
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Ostrava
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Czech Republic
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Prague
Country [19] 0 0
Czech Republic
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Praha
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Czech Republic
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Zlin
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France
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Dijon
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France
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Marseille
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France
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Nantes
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France
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Paris
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Germany
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Ahaus
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Germany
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Darmstadt
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Germany
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Freiburg
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Germany
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Karlsruhe
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Germany
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Leipzig
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Germany
State/province [30] 0 0
Munster
Country [31] 0 0
Germany
State/province [31] 0 0
Saarbruecken
Country [32] 0 0
Israel
State/province [32] 0 0
Afula
Country [33] 0 0
Israel
State/province [33] 0 0
Beer Sheva
Country [34] 0 0
Israel
State/province [34] 0 0
Beer Yakov
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Israel
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Jerusalem
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Israel
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Kfar-Saba
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Israel
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Petah Tikva
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Israel
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Rehovot
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Israel
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Tel Aviv
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Israel
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Tel Hashomer
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Italy
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Firenze
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Italy
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Milano
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Italy
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Rome
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Italy
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Saronno
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Italy
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Udine
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Italy
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Verona
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Poland
State/province [47] 0 0
Bydgoszcz
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Poland
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Gdansk
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Spain
State/province [49] 0 0
Alicante
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Spain
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Barcelona
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Spain
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Oviedo
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Spain
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Santiago de Compostela
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Spain
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Sevilla
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Spain
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Valencia
Country [55] 0 0
Spain
State/province [55] 0 0
Valladolid

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Fovea Pharmaceuticals SA
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study is to determine whether concentrations of FOV2304 (high dose or low dose) administered in the eye are more effective than placebo in treating patients with diabetic macular edema, following 12 weeks of treatment.
Trial website
https://clinicaltrials.gov/study/NCT01319487
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pascale Massin, MD
Address 0 0
Lariboisière Hospital, Paris
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01319487