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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2008-004561-26-IT |
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Date of registration:
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11/11/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Inner Retinal Dysfunction of the Cone System in Inherited Photoreceptor Degenerations: A Study of Disease Sequence and Assessment of Novel Therapeutic Strategies. - ND
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Scientific title:
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Inner Retinal Dysfunction of the Cone System in Inherited Photoreceptor Degenerations: A Study of Disease Sequence and Assessment of Novel Therapeutic Strategies. - ND |
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Date of first enrolment:
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01/06/2009 |
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Target sample size:
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-004561-26 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: yes
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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Italy
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. diagnosi di RP tipica con pattern di disfunzione retinica tipo ?rod-cone?, determinata da esami elettroretinografici con cupola Ganzfeld e dalla perimetria con adattamento al buio, e dal classico aspetto del fondo oculare, 2. funzione centrale retinica parzialmente conservata (campo visivo valutato con mira V/4e > 30, acuita` visiva secondo ETDRS corretta > 20/40), 3. genotipo conosciuto o in valutazione, 4. almeno quattro valutazioni cliniche di follow-up nei precedenti tre anni, 5. assenza di opacita` dei mezzi diottrici, 6. assenza di patologie oculari concomitanti (e.g. glaucoma, ambliopia) o di patologie sistemiche
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Typical RP with a rod-cone pattern of retinal dysfunction, as determined by standard Ganzfeld electroretinography and dark-adapted fundus perimetry, and classic fundus appearance, 2. Relatively preserved central retinal function (visual field by Goldmann V/4e > 30, corrected ETDRS visual acuity > 20/40), 3. Known genotype or genotype under study, 4. At least four follow-up clinical examination over the past three years, 5. No or minimal ocular media opacities, 6. No concomitant ocular (e.g. glaucoma, amblyopia) or systemic diseases
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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retinitis pigmentosa
MedDRA version: 9.1
Level: LLT
Classification code 10038914
Term: Retinitis pigmentosa
MedDRA version: 9.1
Level: PT
Classification code 10038914
Term: Retinitis pigmentosa
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Intervention(s)
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Product Name: Nerve Growt Factor - 2.5S
Pharmaceutical Form: Eye drops, solution
CAS Number: 93928-24-6
Current Sponsor code: N 6009
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Eye drops, solution
Route of administration of the placebo: Ocular use
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: COQUN
Concentration unit: % percent
Concentration type: equal
Concentration number: .1-
Pharmaceutical form of the placebo: Eye drops, solution
Route of administration of the placebo: Ocular use
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Primary Outcome(s)
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Main Objective: to test the hypothesis that an intrinsic, fundamental sequence of adverse events occurs in the inner retina of all individuals affected by inherited photoreceptor degenerations, and that this pathological sequence may be delayed by therapeutic approaches based on neuroprotection.
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Primary end point(s): ND
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Secondary Objective: ND
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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