Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06626971
Status:
TERMINATED
Last Update Posted:
None
First Post:
2018-03-28
Brief Title:
The Use of ARA290 for the Treatment of Diabetic Macular Oedema
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase II Clinical Trial on the Use of ARA 290 for the Treatment of Diabetic Macular Oedema
Status:
TERMINATED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Expiry of study drug - no replacement available
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARA290DMO
Brief Summary:
ARA 290-DMO is a prospective open label interventional single centre investigator led phase II trial to examine the effect of ARA 290 on diabetic macular oedema in patients with type 1 or 2 diabetes
The aim or primary objective of the study was to determine whether ARA 290 administered at a daily dose of 4mg subcutaneously for 12 weeks to patients with diabetes mellitus DM and DMO would have a beneficial effect on mean change in best corrected visual acuity BCVA from baseline values to week 12
The aim or primary objective of the study was to determine whether ARA 290 administered at a daily dose of 4mg subcutaneously for 12 weeks to patients with diabetes mellitus DM and DMO would have a beneficial effect on mean change in best corrected visual acuity BCVA from baseline values to week 12
Detailed Description:
Diabetic retinopathy a very most common cause of sight loss in people of working age Sight loss occurs in diabetes because of diabetic macular oedema DMO andor proliferative diabetic retinopathy PDR both are complications of diabetes in the eye
In DMO fluid accumulates in the macula the area responsible for our central sight As the fluid accumulates the sight drops The current treatments for DMO include laser and anti VEGF drugs and steroids Anti VEGF drugs have been very helpful in the treatment of DMO However anti VEGF drugs need to be given by an injection into the eye an Ophthalmologist eye specialist or a specialist nurse a nurse trained for this purpose will need to deliver this treatment to patients with DMO in the hospital
Furthermore patients require injections every four weeks during the first months of treatment and long term treatment is required Moreover not all patients respond to anti VEGFs In 40 of patients the sight may not improve despite these injections Because many patients with DMO have DMO in both eyes injections need to be given in both eyes to many patients
Given the above facts there appeared a clear need to develop new treatments for people with DMO ARA 290 is a drug that has marked anti-inflammatory properties and has an effect in preventing the death of cells As inflammation is known to play a role in the occurrence of DMO it was thought that ARA 290 could potentially be helpful in treating patients with this condition In light of this the Investigators carried out this study to find out if ARA 290 was effective in drying the fluid in DMO If this treatment was successful benefits may have included a reduction of the demands on health care services and patient benefits of self administration of the drug at home by the patients a reduction in hospital visits treatment of both eyes at once reduced risks associated with injections a more pleasant treatment subcutaneous injection versus an injection into the eye
In DMO fluid accumulates in the macula the area responsible for our central sight As the fluid accumulates the sight drops The current treatments for DMO include laser and anti VEGF drugs and steroids Anti VEGF drugs have been very helpful in the treatment of DMO However anti VEGF drugs need to be given by an injection into the eye an Ophthalmologist eye specialist or a specialist nurse a nurse trained for this purpose will need to deliver this treatment to patients with DMO in the hospital
Furthermore patients require injections every four weeks during the first months of treatment and long term treatment is required Moreover not all patients respond to anti VEGFs In 40 of patients the sight may not improve despite these injections Because many patients with DMO have DMO in both eyes injections need to be given in both eyes to many patients
Given the above facts there appeared a clear need to develop new treatments for people with DMO ARA 290 is a drug that has marked anti-inflammatory properties and has an effect in preventing the death of cells As inflammation is known to play a role in the occurrence of DMO it was thought that ARA 290 could potentially be helpful in treating patients with this condition In light of this the Investigators carried out this study to find out if ARA 290 was effective in drying the fluid in DMO If this treatment was successful benefits may have included a reduction of the demands on health care services and patient benefits of self administration of the drug at home by the patients a reduction in hospital visits treatment of both eyes at once reduced risks associated with injections a more pleasant treatment subcutaneous injection versus an injection into the eye
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None