Lucentis KAV Study

Sponsor

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery (Other)

Overall Status

Completed

CT.gov ID

NCT01570608

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Ranibizumab has been proven to be effective in large multicentre studies. However, the injections have to be repeated monthly. A combined therapy with the established photodynamic therapy might even be more effective, less intravitreal injections might be necessary due to a synergistic effect.

The study will be conducted to explore whether intravitreal ranibizumab in monotherapy or in combination with verteporfin photodynamic therapy under a new time regime is an effective, safe and convenient treatment for patients with subfoveal Choroidal Neovascularisation (CNV) secondary to Age-Related Macular Degeneration (AMD).

Condition or Disease	Intervention/Treatment	Phase
Age Related Macular Degeneration	Drug: Ranibizumab Drug: Verteporfin	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

51 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Comparison of Ranibizumab (Lucentis) Monotherapy Versus Combination of Ranibizumab (Lucentis) With Photodynamic Therapy (Verteporfin) in Patients With Subfoveal Choroidal Neovascularisation Due to Age-Related Macular Degeneration - a Pilot Study

Study Start Date :

Mar 1, 2007

Actual Primary Completion Date :

Aug 1, 2011

Actual Study Completion Date :

Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: monotherapy arm patients receiving 3 initial Ranibizumab injections, thereafter as needed	Drug: Ranibizumab intravitreal injection 3 monthly injections thereafter as needed
Active Comparator: combined treatment arm	Drug: Ranibizumab intravitreal injection 3 monthly injections thereafter as needed Drug: Verteporfin Verteporfin photodynamic therapy standard fluence

Arm

Intervention/Treatment

Active Comparator: monotherapy arm

patients receiving 3 initial Ranibizumab injections, thereafter as needed

Drug: Ranibizumab

intravitreal injection 3 monthly injections thereafter as needed

Active Comparator: combined treatment arm

Drug: Ranibizumab

intravitreal injection 3 monthly injections thereafter as needed

Drug: Verteporfin

Verteporfin photodynamic therapy standard fluence

Outcome Measures

Primary Outcome Measures

number of injections [baseline-month 12]
Comparision of the number of required retreatments between the groups

Secondary Outcome Measures

number of AE, SAE [12 months]
number of AE and SAE
central retinal thickness [baseline-month 12]
central retinal thickness measured by OCT
distance acuity [baseline-month 12]
change of disance acuity measured by ETDRS letter scores

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

BCVA letter score in the study eye between 73-24 (approximately 20/40 to 20/320) using an ETDRS chart measured at 4 meters or Snellen equivalent
CNV lesion of any type in the study eye which meets all the following characteristics as determined by fluorescein angiography:
Evidence that CNV extends under the geometric center of the foveal avascular zone.
The area of the CNV must occupy at least 50% of the total lesion.
The lesion must be ≤ 5400 microns in greatest linear dimension (GLD)
For occult with no classic CNV, additionally recent disease progression as assessed by the Investigator is required defined as having at least one of the following criteria:
Blood associated with the lesion at baseline
Loss of VA in the previous 3 months defined as either ≥ 5 letters (ETDRS equivalent) as determined by protocol refraction and protocol measurements, or 2 or more lines using a Snellen or equivalent chart by standard examinations. ≥ 10% increase in the greatest diameter of the lesion in the previous 3 months as assessed by fluorescein angiography
Willing to return for scheduled visits for a 12 month period
Only one eye will be assessed in the study. If both eyes are eligible, the one with the worse visual acuity will be selected for treatment and study unless, based on medical reasons, the investigator deems the other eye the more appropriate candidate for treatment and study

Exclusion Criteria:

Patients who have a BCVA of < 33 letters (approximately 20/200) in both eyes
Prior treatment in the study eye with verteporfin, external-beam radiation therapy, vitrectomy, submacular surgery, other surgical intervention for AMD, or transpupillary thermotherapy
Previous or current intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye
Focal laser photocoagulation (juxta-, extra- or subfoveal) in the study eye
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 consecutive 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
Current use or of likely need for systemic medications known to be toxic to the lens, retina or optic nerve, including Deferoxamine, Chloroquine/ hydroxychloroquine (Plaquenil), Tamoxifen, Phenothiazines and Ethambutol is excluded
History of glaucoma filtration surgery, corneal transplant surgery or extracapsular extraction of cataract with phacoemulsification within six months preceding Day One, or a history of post-operative complications within the last 12 months preceding Day One in the study eye (uveitis, cyclitis etc.)
History of uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with topical anti-glaucomatous mediation).
Aphakia or absence of the posterior capsule in the study eye
Previous violation of the posterior capsule in the study eye is also excluded unless it occurred as a result of YAG posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation
Spherical equivalent of the refractive error in the study eye demonstrating more than -8 diopters of myopia
Presence of a retinal pigment epithelial tear involving the macula in the study eye
Angioid streaks or precursors of CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia
Active intraocular inflammation (grade trace or above) in the study eye
Any active infection involving an eyeball adnexa
Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Department of OPhthalmology Medical center east	Vienna	Austria	A1030
2	Department of Ophthalmology Rudolf foundation Clinic	Vienna	Austria	A1030
3	Department of Ophthalmology, Hospital Hietzing	Vienna	Austria	A1030