Central Retinal Vein Occlusion, Non-Ischemic Clinical Trial
— PNPRO_HCOfficial title:
Prevention of Retinal Non-perfusion in Central Retinal Vein Occlusion by Hydroxycarbamide Treatment.
The central retinal vein occlusion (CRVO) is a major cause of ocular morbidity, depending in particular on the occurrence and extent of retinal ischemia by capillary occlusion. There is no effective systemic treatment of this condition. An increase in the adhesion of erythrocytes to vascular endothelium was observed for patients with CRVO, correlated with overexpression of membrane phosphatidylserine
| Status | Recruiting |
| Enrollment | 30 |
| Est. completion date | December 2017 |
| Est. primary completion date | August 2017 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 45 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Patients of both sexes of at least 45 years of age. - with social protection - Presenting CRVO for less than 1 month duration - With a decrease of visual acuity and with the best corrected visual acuity lower than 6/10 (73 ETDRS letters) - Signature of informed consent Exclusion Criteria: - predictable lack of compliance to the protocol - monophtalmic patient or any ocular history or condition that could interfere with the study course or results interpretation. - active systemic disease - sickle cell disease - myeloproliferative disease - myelosuppression - kidney or liver insufficiency - ongoing treatment with hydroxycarbamide or anticoagulant - Pregnancy, breast-feeding, no efficient contraception (for both sexes) - wish of paternity (for males of al least 45 years of age) |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | CHNO des Quinze-Vingts | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts | ADDMEDICA SASA, For Drug Consulting, Institut National de la Transfusion Sanguine (INTS), Keyrus, Robert Debré Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | retinal capillary non-perfusion | To assess the percentage of subjects in whom one of the following events will not be observed at W13 (any event being considered as one of the criteria of worsening of retinal capillary non-perfusion): Occurence of at least one direct sign of retinal ischemia: Increase of more than 30% of peripheral retinal non-perfusion on large-field angiography or of the central avascular zone of the retina, Occurence of at least one indirect sign of retinal ischemia: reperfusion of the aterial iris circle, rubeosis iridis, neovascular glaucoma or abolition of the afferent pupillary reflex. |
3 months | Yes |
| Secondary | retinal capillary non-perfusion | Same criteria of retinal non perfusion as for primary end point | 2 weeks, 2 months and 6 months | Yes |
| Secondary | Hydroxycarbamide safety - visual acuity and retinal thickness. Biological in vitro effects on erythrocyte adhesion to vascular endothelium and various haemorheological parameters. | HC effect on visual acuity and retinal thickness. Biological in vitro effects on erythrocyte adhesion to vascular endothelium and various haemorheological parameters. | 2 weks, 2 months, 3 months and 6 months | Yes |