Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00511875
Status:
COMPLETED
Last Update Posted:
2018-11-02
First Post:
2007-08-03
Brief Title:
Evaluation of Doxycycline Verses Placebo for the Treatment of Severe Nonproliferative or Mild or Moderate Proliferative Diabetic Retinopathy
Sponsor:
Thomas Gardner
Organization:
Milton S Hershey Medical Center
Study Overview
Official Title:
Evaluation of Effect of Doxycycline Verses Placebo on Diabetic Retinopathy Progression and Retinal Function in Patients With Severe Non-proliferative or Mild or Moderate Non-high-risk Proliferative Diabetic Retinopathy
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POC1
Brief Summary:
This 24 month randomized research study will evaluate whether doxycycline can 1 slow the deterioration or improve retinal function andor 2 induce regression or slow progression of diabetic retinopathy in participants over 18 years of age with type 1 or type 2 diabetes with severe non-proliferative or early proliferative diabetic retinopathy
Detailed Description:
The objectives of this proof-of-concept study are to investigate whether doxycycline can 1 slow the deterioration or improve retinal function andor 2 induce regression or slow progression of diabetic retinopathy The tests will be performed in the Ophthalmology Departments of the Penn State College of Medicine and Glostrup Hospital Copenhagen Denmark The 24 month proof-of-concept clinical study will involve a prospective randomized double-masked clinical trial including 60 adult patients with type 1 or type 2 diabetes who have severe non-proliferative diabetic retinopathy ETDRS level 53E or mild or moderate proliferative diabetic retinopathy retinal and or optic disk neovascularization less than the high-risk ETDRS level 61 or 65 neovascularization of the disc or neovascularization elsewhere 12 disc area and in whom panretinal photocoagulation is not imminently required in the ophthalmologists judgment
Systemic Exclusion Criteria
unstable medical status eg glycemic control blood pressure cardiovascular disease in the opinion of investigator
significant renal disease defined as a serum creatinine 25 mgdL
systolic blood pressure 180 mm Hg or diastolic blood pressure 110 mm Hg
history of headaches associated with tetracycline therapy
history of pseudotumor cerebri
pregnancy for women of child-bearing potential a serum pregnancy test will be performed
lactating or intending to become pregnant during the study period at least 24 months
sexually active women of child-bearing potential not actively practicing birth control by using a medically accepted device or therapy that is intrauterine device hormonal contraceptive or barrier devices during the study period at least 24 months since doxycycline may interfere with the effectiveness of hormonal contraceptives sexually active women of child-bearing potential who use a hormonal contraceptive will be required to use a second form of contraception to safeguard against contraceptive failure while participating in the study
known allergyintolerance to doxycycline or any ingredient in the study drug or placebo eg cellulose hypromellose iron oxide methacrylic acid copolymer polyethylene glycol polysorbate 80 sugar spheres talc titanium dioxide and triethyl citrate
patients taking phenytoin barbiturates or carbamazepine with gastroparesis with a history of gastrectomy gastric bypass surgery or otherwise deemed achlorhydric or with a BMI 30 kgm2 will also be excluded because of altered doxycycline pharmacokinetics andor bioavailability
patients taking strontium acitretin or tretinoin will be excluded due to the potential for serious drug interactions with doxycycline
patients with abnormal ALT or AST at baseline will be referred to their primary care physician for medical clearance for participation in this study
Systemic Exclusion Criteria
unstable medical status eg glycemic control blood pressure cardiovascular disease in the opinion of investigator
significant renal disease defined as a serum creatinine 25 mgdL
systolic blood pressure 180 mm Hg or diastolic blood pressure 110 mm Hg
history of headaches associated with tetracycline therapy
history of pseudotumor cerebri
pregnancy for women of child-bearing potential a serum pregnancy test will be performed
lactating or intending to become pregnant during the study period at least 24 months
sexually active women of child-bearing potential not actively practicing birth control by using a medically accepted device or therapy that is intrauterine device hormonal contraceptive or barrier devices during the study period at least 24 months since doxycycline may interfere with the effectiveness of hormonal contraceptives sexually active women of child-bearing potential who use a hormonal contraceptive will be required to use a second form of contraception to safeguard against contraceptive failure while participating in the study
known allergyintolerance to doxycycline or any ingredient in the study drug or placebo eg cellulose hypromellose iron oxide methacrylic acid copolymer polyethylene glycol polysorbate 80 sugar spheres talc titanium dioxide and triethyl citrate
patients taking phenytoin barbiturates or carbamazepine with gastroparesis with a history of gastrectomy gastric bypass surgery or otherwise deemed achlorhydric or with a BMI 30 kgm2 will also be excluded because of altered doxycycline pharmacokinetics andor bioavailability
patients taking strontium acitretin or tretinoin will be excluded due to the potential for serious drug interactions with doxycycline
patients with abnormal ALT or AST at baseline will be referred to their primary care physician for medical clearance for participation in this study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT number 2007-005601-22 | None | None | None |