Injection of Lucentis (Ranibizumab) in the vitreous body of the eye after eye surgery and application of recombinant tissue plasminogen activator (rtPA) in patients with submacular bleeding complications suffering from wet age-related macular degeneration (AMD).

• Register: EUCTR
• Last refreshed on: 14 March 2016
• Main ID: EUCTR2010-018637-21-DE
• Date of registration: 17/04/2013
• Prospective Registration: Yes
• Primary sponsor: Universitätsklinikum Schleswig-Holstein UKSH
• Public title: Injection of Lucentis (Ranibizumab) in the vitreous body of the eye after eye surgery and application of recombinant tissue plasminogen activator (rtPA) in patients with submacular bleeding complications suffering from wet age-related macular degeneration (AMD).
• Scientific title: Intravitreal Injection of Lucentis (Ranibizumab) after Pars Plana Vitrectomy and Subretinal Application of Recombinant Tissue Plasminogen Activator (rtPA) in Patients with Acute Submacular Hemorrhage as Complication of Exsudative Age-related Macular Degeneration (AMD). - SubMacHem
• Date of first enrolment: 20/11/2013
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-018637-21
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Germany

Contacts

• Name: Prof. Dr. Jost Hillenkamp
• Affiliation: Universitätsklinikum Schleswig-Holstein, Campus Kiel, Ophthalmic clinic

• Name: Prof. Dr. Jost Hillenkamp
• Affiliation: Universitätsklinikum Schleswig-Holstein, Campus Kiel, Ophthalmic clinic

Key inclusion & exclusion criteria

Inclusion criteria:
1. Exsudative age-related macular degeneration with acut submacular hemorrhage
2. Submacular hemorrhage with involvement of the fovea with a minimum size of 2 papilla-diameters
3. Onset of symptoms = 2 weeks
4. Age = 60 years
5. Written informed consent
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 1
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14

Exclusion criteria:
1. Drug addiction or other diseases, which doesn´t allow the person concerned to assess the character and concequences of the clinical trial
2. Participation in another clinical trial during or within 4 weeks of study entry.
3. Known hypersensitivity to study medication as well as allergy to Fluorescein
4. Any severe concomitant condition, which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol
5. Systemic infection
6. History of stroke, transient ischemic attack or myocardial infarction
7. History of local or systemic treatment with antiangiogenic drugs (Pegaptanib, Ranibizumab, Bevacizumab, Aflibercept, Anecortave Acetate, Protein Kinase C-Inhibitors)
8. The following eye diseases or previous treatments in the study eye:
- History of focal macular laser coagulation
- History of juxta- or extrafoveal laser coagulation within 1 month of study entry
- History of vitrectomy
- History of treatment with verteporfin (photodynamic therapy), irradiation or transpupilar thermotherapy due to macular degeneration
- Current or suspected ocular or periocular infection
- Acute intraocular inflammation
- History of retinal detachment
- Decompensated glaucoma with an intraocular pressure of = 30 mmHg in spite of medical therapy
- History of filtrating glaucoma surgery
- History of corneal grafting
- Other ocular diseases, which in the opinion of the investigator require surgery within duration of study or lead to a visual loss of 2 lines (ETDRS-chart) within duration of study
- Other macular diseases
- Diabetic maculopathy
- Myopia > -6 diopter
- Hyperopia > +6 diopter
- Amblyopia
- Insufficient quality of fundus imaging due to a poor view into the fundus
- Submacular bleeding due to other reasons
- Submacular massive bleeding (= bleeding crosses the equator)
- Scar in the area of the macula


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

exsudative age-related macular degeneration with acut submacular hemorrhage
MedDRA version: 16.1 Level: LLT Classification code 10055305 Term: Macula lutea hemorrhage System Organ Class: 100000004853
MedDRA version: 16.1 Level: LLT Classification code 10067791 Term: Wet macular degeneration System Organ Class: 100000004853

Therapeutic area: Diseases [C] - Eye Diseases [C11]

Intervention(s)

Trade Name: Actilyse®
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: ALTEPLASE
CAS Number: 105857-23-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Trade Name: Lucentis®
Pharmaceutical Form: Solution for injection
INN or Proposed INN: RANIBIZUMAB
CAS Number: 347396-82-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

Main Objective: Feasibility as well as estimation of safety aspects and morphological and functional effects of the study intervention in patients with acute submacular hemorrhage and exsudative age-related macular degeneration.

Primary end point(s): Best corrected visual acuity 16 weeks after operative intervention followed by three intravitreal injections of Lucentis® in comparison to preoperative findings

Timepoint(s) of evaluation of this end point: 16 weeks after operative intervention

Secondary Objective: Not appllicable

Secondary Outcome(s)

Secondary end point(s): (1) Best corrected visual acuity 4 weeks after operative intervention in comparison to preoperative findings
(2) Qualitative evaluation of the displacement/ resorption of submacular hemorrhage from the fovea 4 and 16 weeks after operative intervention
(3) Evaluation of safety of the study therapy 16 weeks after operative intervention followed by three intravitreal injections of Lucentis®

Timepoint(s) of evaluation of this end point: (1) 4 weeks postoperative
(2) 4 and 16 weeks postoperative
(3) 16 weeks postoperative

Source(s) of Monetary Support

Novartis