EUCTR2009-016760-36-PT
Active, not recruiting
Not Applicable
Prospective, randomized, open label phase II study to assess efficacy and safety of Macugen® (pegaptanib 0.3 mg intravitreal injections) plus panretinal photocoagulation (PRP) and PRP (monotherapy) in the treatment of patients with high risk proliferative diabetic retinopathy. -
AIBILI0 sitesNovember 26, 2009
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Proliferative Diabetic Retinopathy.
- Sponsor
- AIBILI
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Type I, or Type II diabetic subjects as defined by the WHO criteria of either gender, and aged \= 18 years.
- •2\. Women must be using effective contraception, be post\-menopausal for at least 12 months prior to trial entry, or surgically sterile.
- •3\. Ability to provide written informed consent.
- •4\. Ability to return for all trial visits.
- •5\. High\-risk proliferative diabetic retinopathy (HR\-PDR) eyes (as defined in section 2\).
- •6\. BCVA at baseline \> 20/320 (25 letters in the ETDRS Chart) in the study eye.
- •7\. Clear ocular media and adequate pupillary dilatation to permit good quality fundus photography.
- •8\. Intraocular pressure \< 21 mmHg
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
Exclusion Criteria
- •1\. Eyes with prior scatter (panretinal)
- •2\. Focal/grid photocoagulation, within the previous 6 months.
- •3\. Fibrovascular proliferation with retinal traction.
- •4\. Other cause of retinal neovascularization (retinal vein occlusion, radiation retinopathy or others).
- •5\. Atrophy/scarring/fibrosis/ hard exudates involving the center of the macula.
- •6\. Subjects who have received YAG laser within the previous 6 months.
- •7\. Peripheral retinal cryoablation, or laser retinopexy (for retinal tears only),
- •8\. Significant media opacities, which might interfere with visual acuity, assessment of toxicity or fundus photography.
- •9\. Subjects should not be entered if there is likelihood that they will require cataract surgery within the following 1 year.
- •10\. Any intraocular surgery within 6 months before trial enrolment.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Phase 2 study evaluating efficacy and safety of PQR309 in patients with relapsed or refractory primary CNS lymphomaRelapsed or refractory primary CNS lymphoma (PCNSL)MedDRA version: 19.0Level: LLTClassification code 10036685Term: Primary central nervous system lymphomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2015-001306-33-ESPIQUR Therapeutics AG50
Active, not recruiting
Phase 1
Phase 2 study evaluating efficacy and safety of PQR309 in patients with relapsed or refractory primary CNS lymphomaRelapsed or refractory primary CNS lymphoma (PCNSL)MedDRA version: 20.0Level: LLTClassification code 10036685Term: Primary central nervous system lymphomaSystem Organ Class: 100000013303Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2015-001306-33-BEPIQUR Therapeutics AG50
Active, not recruiting
Phase 1
Phase 2 study evaluating efficacy and safety of PQR309 in patients with relapsed or refractory primary CNS lymphomaEUCTR2015-001306-33-GBPIQUR Therapeutics AG50
Active, not recruiting
Not Applicable
A randomized, open-label phase II. study evaluating the efficacy and safety of FOLFOX6+Cetuximab versus FOLFIRI+Cetuximab as first line therapy in patients with metastatic colorectal cancerfirst line therapy in patients with metastatic cancerEUCTR2004-002391-42-CZCECOG (Central European Cooperative Oncology Group)150
Terminated
Phase 2
Comparing a new combination of medicines to the normal standard of care chemotherapy treatment given to patients who have been recently diagnosed with acute myeloid leukaemiaISRCTN71474257DIDACT Foundation164