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TerminatedNCT00969293FOV2302Updated Jan 10, 2012

Study to Assess the Safety and Tolerability of a Single Administration of FOV2302 (Ecallantide) in Patients With Macular Edema Associated With Central Retinal Vein Occlusion

A Phase 1 interventional study of FOV2302 (Ecallantide) in Macular Edema and Central Retinal Vein Occlusion, sponsored by Fovea Pharmaceuticals SA. Terminated at 8 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-01-10.

Sponsored by Fovea Pharmaceuticals SA · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
11
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of the study is to evaluate the safety and tolerability of a single administration of FOV2302 (ecallantide) in patients with macular edema associated with central retinal vein occlusion.

Read the detailed description

Occlusive retinal vascular disease is not uncommon. Central retinal vein occlusion (CRVO) is the second most common vision-impairing vascular disorder of the retina following diabetic retinopathy. Severe visual loss from CRVO is caused by a combination of retinal edema and neovascular proliferation and ischemia. Vascular endothelial factors as they stimulate angiogenesis and increase vascular permeability, are majors pathogenic factors in CRVO. Counteracting these neovascular effects provide significant therapeutic benefit to subjects suffering from this disorder. Macular edema in this condition results from a conjunction of several, as yet, partially unknown factors.

Macular edema may occur in diseases causing cumulative injury over many years, such as diabetic retinopathy, or as a result of more acute events, such as branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).

02

Conditions studied

  • Macular Edema
  • Central Retinal Vein Occlusion

Keywords

  • Macular Edema
  • Occlusive retinal vascular disease
  • Central Retinal Vein Occlusion
  • CRVO
03

In context

Macular Edema

848 studies on the registry are indexed under Macular Edema; 57 are open to participants now.

This study's enrollment of 11 is below the median of 50 across 624 interventional studies indexed under Macular Edema.

Browse Macular Edema studies →

Lead sponsor

Fovea Pharmaceuticals SA is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Recent onset (\< 6 months), non-ischemic CRVO (defined as association of documented retinal hemorrhage in all 4 quadrants of the retina with dilated veins) in patients who have not received treatment for their condition (e.g., no periocular depot or intraocular treatment [including corticosteroid and anti-VEGF], systemic corticosteroids or laser nor hemodilution).
  • Retinal thickness measured by Stratus OCT > 250µm in the central subfield of study eye at baseline.
  • BCVA score (measured by the ETDRS chart between 5 letters (20/800 Snellen equivalent) and 65 letters (20/50) in the study eye at baseline.
  • Media clarity, pupillary dilation and participant cooperation sufficient for adequate fundus photographs.
  • Females of childbearing potential using adequate birth control at Day 0 until study completion.
  • Patient able (in the opinion of the investigator) and willing to return for all scheduled visits and assessments.
  • Ability to read, understand and willingness to provide informed consent.

Exclusion criteria

Exclusion Criteria:

  • Rubeosis iridis or neovascular glaucoma at baseline.
  • Preretinal neovascularisation at baseline.
  • Ischemic CRVO, defined by more than 10 disc area of non-perfusion on fluorescein angiography at baseline.
  • Any grade of diabetic retinopathy.
  • Other eye condition that could contribute to macular edema or cause retinal vascular changes (including vitreomacular traction, uveitis and inflammatory disease, etc).
  • Patients who have received treatment for their condition (e.g., no periocular depot or intraocular treatment [including corticosteroid and anti-VEGF], systemic corticosteroids or laser nor hemodilution).
  • Ocular surgery (including cataract extraction, scleral buckle, etc.) and/or YAG capsulotomy within 3 months preceding treatment date or anticipated within the 3 months following treatment administration.
  • Poorly controlled ocular hypertension and/or glaucoma (IOP greater than 25 mmHg despite maximal therapy).
  • History of pars plana vitrectomy.
  • Aphakia or anterior chamber intraocular lens.
  • Presence of visible sclera thinning or ectasia.
  • Presence of substantial cataract or other media opacity that, in the opinion of the investigator, is likely to interfere with visualization of the fundus or completion of study measurements.
  • Any active ocular or peri-ocular infection (including conjunctivitis, chalazion or significant blepharitis).
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
11 participants (actual)

Interventions

  • Single intravitreal injection into the relevant eye. Five dose levels will be studied from 5 to 90µg and a maximum of 6 subjects will be included at each dose level. Duration of Treatment: Single injection with 3 months follow-up.

06

What researchers measure

Primary outcomes

  1. Safety and tolerability parameters to determine MTD: 1. Systemic parameters: adverse events (AEs), coagulation parameters (APTT, ACT) 2. Ophthalmologic parameters: BCVA, OCT, ocular inflammation, IOP

    Time frame: 3 months post-dose

Secondary outcomes

  1. Assess the pharmacodynamics up to five dose levels of a single administration of FOV2302 (ecallantide) by longitudinal measurements of the percent change of the macula thickness versus baseline as measured by OCT

    Time frame: 3 months post-dose

07

Study locations

8 sites
  • CHU d'Amiens, Centre Saint-Victor
    Amiens, 80054, France
  • Centre Intercommunal de Creteil
    Créteil, 94010, France
  • CHU de Dijon, Hôpital Général
    Dijon, 21000, France
  • Clinique Monticelli
    Marseille, 13008, France
  • CHU de Nantes
    Nantes, 44093, France
  • Centre Hospitalier National d'Ophthalmologies des XV-XX
    Paris, 75012, France
  • Hopital Lariboisiere
    Paris, 75015, France
  • Fondation Rothschild
    Paris, 75571, France
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2009, a primary completion of Jul 2011 and a completion of Mar 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 31, 2009
First posted
Sep 1, 2009
Start
Sep 2009
Primary completionActual
Jul 2011
CompletionEst.
Mar 2012
Last update
Jan 10, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 10, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00969293
Lead sponsor
Fovea Pharmaceuticals SA
Responsible party
Sponsor
First posted
Sep 1, 2009
Start date
Sep 2009
Primary completion
Jul 2011
Completion
Mar 2012 (estimated)
Last update
Jan 10, 2012

Study contacts

Alain Gaudric, MD
study chair · Hopital Lariboisiere

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Ecallantide

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