Diabetic Macular EdemaPhase 2NCT01319487
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
A Phase 2 study testing 2304 Eye Drops High Dose and 2304 Eye Drops Low Dose in people with Diabetic Macular Edema, run by Fovea Pharmaceuticals SA at 65 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- 2304 Eye Drops High Dose and 2304 Eye Drops Low Dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 267 participants
- Where
- 65 sitesin 10 countries
- Study dates
- May 2011to Jun 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, at least 18 years of age.
- Diagnosis of diabetes mellitus
- Patient must be able to self administer study drug.
- Clinically significant diabetic macular edema in at least one eye ("study eye") involving the center of the macula:
- Mild to severe non proliferative diabetic retinopathy (Early Treatment Diabetic Retinopathy Study [ETDRS] grade between 20 and 53).
- BCVA score ≥ 34 letters and < 80 letters in the study eye.
- 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.
- Male patients with partners of childbearing potential must agree to use at least one highly effective method of contraception throughout the study.
Who cannot join
- Ocular conditions:
- Any ocular condition in the study eye that in the opinion of the investigator would prevent improvement in visual acuity.
- Proliferative diabetic retinopathy in the study eye.
- 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.
- Active optic disc or retinal neovascularization, rubeosis iridis, active or history of choroidal neovascularization in the study eye.
- History of pars plana vitrectomy at any time, intraocular surgery in the study eye within 90 days prior to screening.
Show all 23Show fewer
- 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.
- 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.
- Patients who have previously received anti-VEGF therapy within 3 months prior to the screening visit in the study eye.
- Uncontrolled glaucoma or glaucoma treated by 2 or more medications.
- Aphakia or intraocular lens placement in the anterior chamber of the study eye.
- Any active ocular infection; any history of recurrent or chronic infection or inflammation in the study eye.
- History of herpetic infection in either eye.
- History of corneal pathology/surgery
- Contact lens use at any time during the study.
- Systemic conditions:
- Uncontrolled systemic disease.
- Poorly controlled diabetes mellitus.
- Impaired renal function
- Poorly controlled arterial hypertension
Trial locations and contacts
65 sites in 10 countries.
65 sites in 10 countries
United States14 sites
Center 1101
Boston, Massachusetts
Center 1109
Boston, Massachusetts
Center 1111
Boston, Massachusetts
Center 1106
Chicago, Illinois
Center 1108
Fort Myers, Florida
Center 1105
Indianapolis, Indiana
Center 1107
Lynbrook, New York
Center 1104
Nashville, Tennessee
Center 1115
Phoenix, Arizona
Center 1116
Phoenix, Arizona
Center 1110
Pittburgh, Pennsylvania
Center 1103
San Antonio, Texas
Center 1112
Toms River, New Jersey
Center 1114
Traverse, Michigan
Israel9 sites
Center 1907
Afula
Center 1906
Beer Yakov
Center 1909
Beersheba
Center 1903
Jerusalem
Center 1908
Kfar Saba
Center 1902
Petah Tikva
Center 1901
Rehovot
Center 1904
Tel Aviv
Center 1905
Tel HaShomer
Spain8 sites
Center 1205
Alicante
Center 1201
Barcelona
Center 1202
Barcelona
Center 1204
Oviedo
Center 1206
Santiago de Compostela
Center 1208
Seville
Center 1209
Valencia
Center 1203
Valladolid
Germany7 sites
Center 1504
Ahaus
Center 1502
Darmstadt
Center 1503
Freiburg im Breisgau
Center 1501
Karlsruhe
Center 1506
Leipzig
Center 1507
Münster
Center 1505
Saarbrücken
Italy7 sites
Center 1604
Florence
Center 1601
Milan
Center 1607
Milan
Center 1610
Rome
Center 1606
Saronno
Center 1608
Udine
Center 1609
Verona
Czechia6 sites
Center 1704
Brno
Center 1701
Hradec Králové
Center 1703
Ostrava
Center 1702
Prague
Center 1705
Prague
Center 1706
Zlín
France5 sites
Center 1401
Dijon
Center 1402
Marseille
Center 1405
Nantes
Center 1403
Paris
Center 1404
Paris
Australia4 sites
Center 2003
Chatswood
Center 2002
Melbourne
Center 2004
Murdoch
Center 2001
Sydney
About this study
Official 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
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.
- Conditions
- Diabetic Macular Edema
- Being tested
- 2304 Eye Drops High Dose, 2304 Eye Drops Low Dose, Placebo Eye Drops
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2304 Eye Drops High DoseDrug
2304 Eye Drops High Dose self-administered in the study eye during the treatment period
2304 Eye Drops Low DoseDrug
2304 Eye Drops Low Dose self-administered in the study eye during the treatment period
Placebo Eye DropsDrug
Placebo Eye Drops self-administered in the study eye during the treatment period
| Study group | Role | What they receive |
|---|---|---|
| 2304 Eye Drops High Dose | Experimental | 2304 Eye Drops High Dose self-administered in the study eye during the treatment period Receives: Drug: 2304 Eye Drops High Dose |
| 2304 Eye Drops Low Dose | Experimental | 2304 Eye Drops Low Dose self-administered in the study eye during the treatment period Receives: Drug: 2304 Eye Drops Low Dose |
| Placebo Eye Drops | Placebo comparator | Placebo Eye Drops self-administered in the study eye during the treatment period Receives: Drug: Placebo Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline of central retinal thickness as determined by logOCT
Measured: Week 12
Secondary outcomes (2)
Proportion of patients with an improvement in best corrected visual acuity (BCVA)
Measured: Week 12
Change in macular volume and retinal thickness from baseline to Week 12 and Week 24
Measured: Baseline, Week 12, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2011 (estimated)
- Study startMay 2011
- Primary completionMar 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fovea Pharmaceuticals SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pascale Massin, MD, Study chair, Lariboisière Hospital, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01319487
- Sponsor's protocol ID
- FOV2304/CLIN/201/P
- Status last verified
- Aug 2012
- First submitted
- 18 Mar 2011
- Last updated
- 23 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01319487
- Acronym / sponsor ID
- FOV2304/CLIN/201/P
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Fovea Pharmaceuticals SAIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 21 Mar 2011 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2304 Eye Drops High Dose | Experimental | Drug: 2304 Eye Drops High Dose2304 Eye Drops High Dose self-administered in the study eye during the treatment period |
| 2304 Eye Drops Low Dose | Experimental | Drug: 2304 Eye Drops Low Dose2304 Eye Drops Low Dose self-administered in the study eye during the treatment period |
| Placebo Eye Drops | Placebo comparator | Drug: Placebo Eye DropsPlacebo Eye Drops self-administered in the study eye during the treatment period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female, at least 18 years of age.
- Diagnosis of diabetes mellitus
- Patient must be able to self administer study drug.
- Clinically significant diabetic macular edema in at least one eye ("study eye") involving the center of the macula:
- Mild to severe non proliferative diabetic retinopathy (Early Treatment Diabetic Retinopathy Study [ETDRS] grade between 20 and 53).
Key exclusion criteria (23 listed)
- Any ocular condition in the study eye that in the opinion of the investigator would prevent improvement in visual acuity.
- Proliferative diabetic retinopathy in the study eye.
- 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.
- Active optic disc or retinal neovascularization, rubeosis iridis, active or history of choroidal neovascularization in the study eye.
- History of pars plana vitrectomy at any time, intraocular surgery in the study eye within 90 days prior to screening.
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 |
|---|---|---|
| 2304 Eye Drops High Dose2304 Eye Drops High Dose self-administered in the study eye during the treatment period | Drug | 2304 Eye Drops High Dose |
| 2304 Eye Drops Low Dose2304 Eye Drops Low Dose self-administered in the study eye during the treatment period | Drug | 2304 Eye Drops Low Dose |
| Placebo Eye DropsPlacebo Eye Drops self-administered in the study eye during the treatment period | Drug | Placebo Eye Drops |
Primary outcome
change from baseline of central retinal thickness as determined by logOCT
Time frame: Week 12
2 secondary outcomes
Proportion of patients with an improvement in best corrected visual acuity (BCVA)
Time frame: Week 12
Change in macular volume and retinal thickness from baseline to Week 12 and Week 24
Time frame: Baseline, Week 12, Week 24
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 23 Aug 2012.
Related trials for Diabetic Macular Edema
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingPhase 3
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Diabetic Macular Edema, DME
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.
Pascale Massin, MD study chair
Lariboisière Hospital, Paris
65 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 2304 Eye Drops High Dose and 2304 Eye Drops Low Dose in people with Diabetic Macular Edema, run by Fovea Pharmaceuticals SA at 65 sites in 10 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 8 inclusion and 23 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 23 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in United States, Israel, Spain, Germany, Italy and 5 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. Some participants in this study may receive a placebo. 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?
change from baseline of central retinal thickness as determined by logOCT (time frame: Week 12). 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 23 Aug 2012.