Prospective, randomized, multicenter, open label, phase II / III study to assess efficacy and safety of ranibizumab 0.5 mg intravitreal injections plus panretinal photocoagulation (PRP) versus PRP in monotherapy in the treatment of subjects with high risk proliferative diabetic retinopathy. (PROTEUS)
- Conditions
- Patients with type I or type II diabetes mellitus and high risk diabetic retinopathy.MedDRA version: 17.1Level: LLTClassification code 10036857Term: Proliferative diabetic retinopathySystem Organ Class: 100000004853Therapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2013-003640-23-PT
- Lead Sponsor
- AIBILI - Association for Innovation and Biomedical Research on Light and Image
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 94
1.High-risk proliferative diabetic retinopathy (HR-PDR);
i. Neovascularization in the disc = 1/4 disc area OR Neovascularization Elsewhere = 1/2 disc area;
ii. Neovascularization Elsewhere < 1/2 disc area + vitreous and/or pre-retinal haemorrhage and/or rubeosis;
iii. Neovascularization in the disc <1/4 disc area + vitreous and/or pre-retinal haemorrhage and/or rubeosis;
2. Best-corrected visual acuity at baseline = 24 ETDRS letters score (approximate Snellen equivalent 20/320).
3. Type I or Type II diabetic subjects of either gender;
4. Age = 18 years;
5. Ability to provide written informed consent;
6. Ability to return for all clinical trial visits.
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 47
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 47
1. Any intraocular surgery within 6 months before trial enrolment,
including:
a. Prior scatter (panretinal) or focal/grid photocoagulation;
b. Eyes who have received YAG laser, or peripheral retinal cryoablation,
or laser retinopexy (for retinal tears only);
2. Fibrovascular proliferation with retinal traction;
3. Other cause of retinal Neovascularization (retinal vein occlusion,
radiation retinopathy or others);
4. Atrophy/scarring/fibrosis/ hard exudates involving the centre of the
macula;
5. Significant media opacities or inadequate pupillary dilation, which
might interfere with visual acuity, assessment of toxicity or fundus
photography;
6. Any likelihood that the subject will require cataract surgery within the
following 1 year;
7. Diabetic macular edema with central involvement, i.e., central macular
thickness (Central Point Thickness) > 300 ìm (Stratus OCT) equivalent
values measured by SD-OCT, adjusted according to the SD-OCT machine
used;
8. Previous vitrectomy;
9. Intraocular pressure > 21 mmHg;
10. Previous anti-VEGF therapy within the last 3 months;
11. Previous treatment with periocular and/or intravitreal
corticosteroids within the last 3 months;
12. Known serious allergies or history of hypersensitivity to fluorescein
used in angiography, or to components of Lucentis® formulation;
13. Acute ocular or periocular infection;
14. Active severe ocular or periocular inflammation;
15. Previous filtering surgery (e.g., trabeculectomy) or placement of a
glaucoma drainage device (e.g., tube-shunt surgery).
16. Systolic BP > 170 mmHg or diastolic BP > 100 mmHg;
17. HbA1C level = 11% or recent signs of uncontrolled diabetes;
18. Any of the following underlying systemic diseases:
a. History or evidence of severe cardiac disease, e.g. NYHA Functional
Class III or IV, clinical or medical history of unstable angina, acute
coronary syndrome, myocardial infarction, or revascularization
procedure within 6 months prior to baseline, or ventricular
tachyarrhythmia requiring treatment;
b. History or evidence of clinically significant peripheral vascular disease
such as intermittent claudication or prior amputation;
c. Renal failure requiring dialysis or renal transplant or renal
insufficiency with creatinine levels > 2.0 mg/dl at screening;
d. Stroke (within 12 months of trial entry);
e. Any major surgical procedure within one month before trial
enrolment;
19. Subject with a condition (such as advanced, severe or unstable
disease or its treatment) or is in a situation which may put him/her at
significant risk, which may confound the study results or may interfere
significantly with the subject's participation in the study;
20. Previous radiation to the head in the region of the study eye;
21. Use of any other investigational drugs within the last 3 months (for
Diabetic Retinopathy or other condition);
22. History of malignancy of any organ system (other than localized
basal cell carcinoma of the skin), treated or untreated, within the past 5
years, regardless of whether there is evidence of local recurrence or
metastases;
23. Pregnant or nursing (lactating) women, where pregnancy is defined
as the state of a female after conception and until the termination of
gestation.
24. Women of child-bearing potential, defined as all women
physiologically capable of becoming pregnant UNLESS they are: using a
highly effective method of birth control (i.e. one that results in a less
than 1% per
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method