Diabetic Retinopathy MedDRA version: 9.1 Level: LLT Classification code 10054109 Term: Non-proliferative diabetic retinopathy
Conditions
Interventions
Trade Name: macugen
Pharmaceutical Form: Solution for injection
INN or Proposed INN: pegaptanib
CAS Number: 222716-86-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numb
Sponsors
Frimley Park Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)TypeI or Type II Diabetes 2)Serum HbA1C >5.5% and 19 letters 6)Male or female patients at least 18 years of age. Female subjects either of non child bearing potenial (hysterectomised or believed to be post menopausal as evidenced by a three yera history of amenorrhoea) or of cild bearing age are eligible, provided they have a negative urinary pregnancy test at the screening and baseline visit. Female subjects of child bearing potential should be willing to use adequate (atleast to forms of) contraceptive methods as described below during the treatment period and for three months after the last dose of study medication. Male subjects with partners of child bearing potential must agree to use adequate (at least one form of) contaception as described below during the treatment period and for three months after the last dose of study medication or be surgically sterile. Acceptable contraceptive methods for female (need at least two) • Hormonal methods of contraception (including oral and transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone- releasing IUDs) at least 14 days prior to the first dose of trial medication • Abstinence • Placement of a copper containing device • Condom with spermicidal foam / gel film/ cream/ suppository • Tubal ligation • Male partner who has had a vasectomy for at least 4 months Acceptable contraceptive methods for male (need at least one) • Abstinence • Use of condoms for males with a vasectomy • Without a vasectomy, must use a condom and be instructed that their female partner should use another form of contraception such as IUD, spermicidal foam/ gel/cream/suppository, diaphragm with spermicide, oral contraceptive, injectable progesterone, subdermal implant or tubal ligation if the female partner could become pregnant from the first dose of medication until three months after the last dose. 7) Patients who provide written and informed consent according to legal requirements, and who have signed the consent form prior to initiation of any study procedure Are the trial subjects under 18? no 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Active intraocular or periocular inflammation 2) History of intraocular surgeries within the last 2 months in the study eye 3) Current treatment with any other investigational product 4) Retinal vascular diseases 5) Uncontrolled glaucoma (With antiglaucoma medications intraocular pressure more than 30 mmof Hg and or advanced disc cupping with glaucomatous field loss) 6) Planned or anticipated need for cataract surgery during the 12month study period 7) Pregnant or lactating women 8) Other retinal diseases that might affect the outcome (except diabetic maculopathy) Others • Allergy to FFA • Allergy to Iodine • Inability to obtain colours, fluorescein angiography of sufficient quality. • Allergy to anti VEGF medications. • Allergy to humanised monoclonal antibody. • Inability to comply with follow up procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study is designed to evaluate the safety and explore the effects of Macugen in eyes with severe non proliferative diabetic retinopathy(ETDRS 53A-E).The objective of the study is to assess whether Macugen given at these time points of diabetic retinopathy can prevent the conversion to sight threatening proliferative diabetic retinopathy.;Secondary Objective: 1. 1. The proportion of eyes that progress to ETDRS =61 or above following three injections of intravitreal Macugen compared to control eyes receiving standard care (no treatment) at 24 months. 2. The rate (time point) of development of neovascularisation in treated eyes will be compared to control eyes. 3. Rates of ocular and non-ocular adverse events. 4. The visual outcome in the study eye will be compared to control eyes 5. The mean change in size of FAZ from baseline to end of 12 months and 24 months in treated eyes will be compared to control eyes. ;Primary end point(s): The proportion of eyes that progress to ETDRS =61 following three injections of intravitreal Macugen compared to control eyes receiving standard care (no treatment) at 12 months. | — |
Countries
United Kingdom
Outcome results
None listed