Clinical Trial: Trial to Assess the Efficacy of Neuroprotective Drugs Administered Topically to Prevent or Arrest Diabetic Retinopathy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Neurodegeneration as Early Event in Pathogenesis of Diabetic Retinopathy:Multicentric, Prospective, Ph. II-III,Random.Controlled Trial to Assess Efficacy of Neuroprotectiv
Brief Summary: To assess whether neuroprotective drugs administered topically (somatostatin and brimonidine) are able to prevent or arrest the development and progression of neurodegenerative changes
Detailed Summary: To assess whether neuroprotective drugs administered topically (somatostatin and brimonidine) are able to prevent or arrest the development and progression of neurodegenerative changes related to diabetic retinopathy.
Sponsor: BCN Peptides
Current Primary Outcome: Changes in the Implicit Time assessed by mfERG (IT-mfERG) at month 6, 12, 18 and 24 [ Time Frame: month 24 ]
Original Primary Outcome:
- Changes in the Implicit Time assessed by mfERG (IT-mfERG)at month 0 [ Time Frame: month 0 ]
- Changes in the Implicit Time assessed by mfERG (IT-mfERG)at month 6 [ Time Frame: month 6 ]
- Changes in the Implicit Time assessed by mfERG (IT-mfERG)at month 12 [ Time Frame: month 12 ]
- Changes in the Implicit Time assessed by mfERG (IT-mfERG)at month 18 [ Time Frame: month 18 ]
- Changes in the Implicit Time assessed by mfERG (IT-mfERG)at month 24 [ Time Frame: month 24 ]
Current Secondary Outcome:
- Retinal Nerve Fiber Layer (RNFL) assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) at month 0 [ Time Frame: month 0 ]
- Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 6 [ Time Frame: month 6 ]
- Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 12 [ Time Frame: month 12 ]
- Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 18 [ Time Frame: month 18 ]
- Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 24 [ Time Frame: month 24 ]
- Ganglion Cell Layer (GCL) assessed by SD-OCT at month 0 [ Time Frame: month 0 ]
- Ganglion Cell Layer (GCL) assessed by SD-OCT at month 6 [ Time Frame: month 6 ]
- Ganglion Cell Layer (GCL) assessed by SD-OCT at month 12 [ Time Frame: month 12 ]
- Ganglion Cell Layer (GCL) assessed by SD-OCT at month 18 [ Time Frame: month 18 ]
- Ganglion Cell Layer (GCL) assessed by SD-OCT at month 24 [ Time Frame: month 24 ]
- Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at baseline [ Time Frame: baseline ]
- Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 6 [ Time Frame: month 6 ]
- Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 12 [ Time Frame: month 12 ]
- Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 18 [ Time Frame: month 18 ]
- Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 24 [ Time Frame: month 24 ]
- Retinal thickness assessed by SD-OCT at month 0 [ Time Frame: month 0 ]
- Retinal thickness assessed by SD-OCT at month 6 [ Time Frame: month 6 ]
- Retinal thickness assessed by SD-OCT at month 12 [ Time Frame: month 12 ]
- Retinal thickness assessed by SD-OCT at month 18 [ Time Frame: month 18 ]
- Retinal thickness assessed by SD-OCT at month 24 [ Time Frame: month 24 ]
- Central retinal thickness assessed by SD-OCT at month 0 [ Time Frame: month 0 ]
- Central retinal thickness assessed by SD-OCT at month 6 [ Time Frame: month 6 ]
- Central retinal thickness assessed by SD-OCT at month 12 [ Time Frame: month 12 ]
- Central retinal thickness assessed by SD-OCT at month 18 [ Time Frame: month 18 ]
- Central retinal thickness assessed by SD-OCT at month 24 [ Time Frame: month 24 ]
- Diabetic Retinopathy (DR) severity assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) scale CFP - 30º/35º-7 fields at baseline [ Time Frame: baseline ]
- DR severity assessed by ETDRS scale CFP - 30º/35º-7 fields at month 24 [ Time Frame: month 24 ]
Original Secondary Outcome: Same as current
Information By: BCN Peptides
Dates:
Date Received: November 7, 2012
Date Started: February 2013
Date Completion:
Last Updated: January 11, 2016
Last Verified: January 2016