Prospective, Randomized, Open Label, Phase II Study to Assess Efficacy and Safety of Macugen® (Pe⦠(NCT01281098) | Clinical Trial Compass
CompletedPhase 2
Prospective, Randomized, Open Label, Phase II Study to Assess Efficacy and Safety of MacugenĀ® (Pegaptanib 0.3 mg Intravitreal Injections) Plus Panretinal Photocoagulation and PRP (Monotherapy) in the Treatment With High Risk PDR.
Portugal22 participantsStarted 2010-03
Plain-language summary
To evaluate the safety and determine the efficacy of PRP monotherapy or combination therapy (pegaptanib 0.3 mg plus PRP) in patients with Type I or Type II diabetes mellitus and with high risk proliferative diabetic retinopathy.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* High-risk proliferative diabetic retinopathy (HR-PDR) eyes (as defined in section 2).
* BCVA at baseline \> 20/320 (25 letters in the ETDRS Chart) in the study eye.
* Clear ocular media and adequate pupillary dilatation to permit good quality fundus photography.
* Intraocular pressure \< 21 mmHg.
* Type I, or Type II diabetic subjects as defined by the WHO criteria of either gender, and aged ā„ 18 years.
* Women must be using effective contraception, be post-menopausal for at least 12 months prior to trial entry, or surgically sterile.
* Ability to provide written informed consent.
* Ability to return for all trial visits.
Exclusion Criteria:
* Eyes with prior scatter (panretinal).
* Focal/grid photocoagulation, within the previous 6 months.
* Fibrovascular proliferation with retinal traction.
* Other cause of retinal neovascularization (retinal vein occlusion, radiation retinopathy or others).
* Atrophy/scarring/fibrosis/ hard exudates involving the center of the macula.
* Subjects who have received YAG laser within the previous 6 months.
* Peripheral retinal cryoablation, or laser retinopexy (for retinal tears only),
* Significant media opacities, which might interfere with visual acuity, assessment of toxicity or fundus photography.
* Subjects should not be entered if there is likelihood that they will require cataract surgery within the following 1 year.
* Any intraocular surgery within 6 months before trial enrolment.
* Previous vitrectomy.
* HbA1ā¦
What they're measuring
1
Regression of retinal neovascularization
Timeframe: 12-month treatment
Trial details
NCT IDNCT01281098
SponsorAssociation for Innovation and Biomedical Research on Light and Image