An academic monocenter study assessing the safety and efficacy of Lucentis (ranizumab 0.3 mg) administered in conjunction with photodynamic therapy with Visudyne in patients with occult or predominantly classic subfoveal choroidal neovascularization secondary to age-related macular degeneration. - COMBO
- Conditions
- Male and female patients =50 years of age with subfoveal choroidal neovascularisation lesions secondary to age related macular degeneration, either predominantly classic or occult with no classic component.
- Registration Number
- EUCTR2006-003976-36-BE
- Lead Sponsor
- Professor Anita Leys - Dienst Oftalmologie UZ St. Rafaël
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1.Patients 50 years of age or greater and woman post menopausal.
2. Patients with subfoveal choroidal neovascularisation lesions secondary to AMD, either predominantly classic with VA > 0.1 (Snellen) or occult with no classic component and with VA < 0.4 and > 0.1
3. CNV lesion in the study eye is =5400 microns in greatest linear dimension.
4. Willing to return for scheduled visits for a 4 month period.
5. Only one eye will be assessed in the study.
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
1. Patients who have a BCVA of < 0.1 in both eyes.
2. Prior treatment in the study eye with verteporfin, external-beam radiation therapy, subfo-veal focal laser photocoagulation, vitrectomy, submacular surgery, or transpupillary ther-motherapy.
3. Previous or current intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye.
4. Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within one month preceding Day 1.
5. Concomitant use of chronic NSAIDs or steroids (by any route) for the duration of study participation (chronic use is defined as multiple doses taken daily for three or more con-secu¬tive days at any time during the study). Note that ASA (aspirin) taken as low dose” up to 100 mg qd for prophylaxis of MI and/or stroke is permitted during study.
6. Current use or of likely need for systemic medications known to be toxic to the lens, ret-ina or optic nerve, including Deferoxamine, Chloroquine/ hydroxychloroquine (Plaquenil), Tamoxifen, Phenothiazines and Ethambutol is excluded.
7. History of glaucoma filtration surgery, corneal transplant surgery or extracapsular ex¬traction of cataract with phacoemulsification within six months preceding Day One, or a his¬tory of post-operative complications within the last 12 months preceding Day One in the study eye (, uveitis, cyclitis etc.) .
8. History of uncontrolled glaucoma in the study eye (defined as intraocular pressure = 25 mmHg despite treatment with anti-glaucoma mediation).
9. History of submacular surgery or other surgical intervention for AMD in the study eye within two months preceding Day 1.
10. Aphakia or absence of the posterior capsule in the study eye.
11. Previous violation of the posterior capsule in the study eye is also excluded unless it oc-curred as a result of YAG posterior capsulotomy in association with prior, posterior cham-ber intraocular lens implantation.
12. Spherical equivalent of the refractive error in the study eye demonstrating more than –8 diopters of myopia.
13. Presence of a retinal pigment epithelial tear involving the macula in the study eye
14. Angioid streaks or precursors of CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia.
15. Active intraocular inflammation (grade trace or above) in the study eye.
16. Any active infection involving eyeball adnexa.
17. Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye.
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